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Recent FDA Drug Approval Process News

Biotechnology and pharmaceutical stocks often move sharply in response to FDA decisions, so knowing what’s coming can give you a critical edge.

MarketBeat’s FDA Drug Approval Calendar is your go-to resource for staying ahead of critical biotech catalysts. This tool helps you navigate the high-stakes world of drug development by tracking key milestones like Prescription Drug User Fee Act (PDUFA) dates, New Drug Applications (NDAs), Biologics License Applications (BLAs), Complete Response Letters (CRLs), and special designations like Breakthrough Therapy or Orphan Drug status.

The calendar makes it easy to filter by company, drug, event type, or date. Whether you're anticipating a market-moving approval or reviewing past decisions, this resource puts the FDA pipeline in sharp focus, allowing you to make investment decisions with confidence.

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Main Company Current Price 30-Day Price Change Drug Status Event
Merck & Co., Inc. stock logo
MRK
Merck & Co., Inc.
$83.96
+6.8%
-0.2%
The price history of MRK in the last 30 days
sotatercept-csrk In adults with pulmonary arterial hypertension
Phase 3
9/30/2025 - Positive Results Merck announced positive results from the Phase 3 HYPERION trial evaluating WINREVAIR™ (sotatercept…
Full Summary
Upstream Bio, Inc. stock logo
UPB
Upstream Bio
$18.81
+8.5%
+9.8%
The price history of UPB in the last 30 days
Verekitug In Chronic Obstructive Pulmonary Disease (COPD) 9/30/2025 - Data Upstream Bio, Inc today presented structural and mechanistic data showing verekitug's potent pharmac…
Full Summary
aTyr Pharma, Inc. stock logo
LIFE
aTyr Pharma
Efzofitimod Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD)
Phase 3
9/30/2025 - Findings Update aTyr Pharma, Inc. today presented additional findings from the Phase 3 EFZO-FIT™ study of efzofitimo…
Full Summary
Ocular Therapeutix, Inc. stock logo
OCUL
Ocular Therapeutix
$11.69
-6.7%
-4.3%
The price history of OCUL in the last 30 days
AXPAXLI In Diabetic Retinopathy 9/30/2025 - Provided Update Ocular Therapeutix, Inc. announce plans for a registrational program in non-proliferative diabetic r…
Full Summary
Ocuphire Pharma, Inc. stock logo
OCUP
Ocuphire Pharma
OPGx-LCA5 For LCA5 Phase 1/2 9/30/2025 - Positive Data Opus Genetics, Inc. announced positive three-month data from the pediatric cohort of its ongoing Pha…
Full Summary
Precision BioSciences, Inc. stock logo
DTIL
Precision BioSciences
$5.52
+8.4%
+12.7%
The price history of DTIL in the last 30 days
ARCUS Eliminate DNA of living cells and organisms. 9/30/2025 - Late Breaking Presentation Precision BioSciences, Inc. announced a late-breaking poster presentation at the 30th Annual Inter…
Full Summary
Precision BioSciences, Inc. stock logo
DTIL
Precision BioSciences
$5.52
+8.4%
+12.7%
The price history of DTIL in the last 30 days
ARCUS Eliminate DNA of living cells and organisms. 9/30/2025 - Provided Update Precision BioSciences, Inc announced that its On track to file an IND and/or CTA by the end of 20…
Full Summary
Nuvation Bio Inc. stock logo
NUVB
Nuvation Bio
$3.70
+14.9%
+24.4%
The price history of NUVB in the last 30 days
IBTROZI In Advanced ROS1-Positive Non-Small Cell Lung Cancer
Phase 3
9/30/2025 - Enrollment Update Nuvation Bio Inc announced it has enrolled the first patient in TRUST-IV (NCT07154706), a Phase 3 st…
Full Summary
SCYNEXIS, Inc. stock logo
SCYX
SCYNEXIS
$0.77
-26.7%
-7.4%
The price history of SCYX in the last 30 days
SCY-247 For systemic fungal diseases
Phase 1
9/30/2025 - Positive Results SCYNEXIS, Inc. announced positive results from a Phase 1 study of SCY-247, its second-generation tr…
Full Summary
electroCore, Inc. stock logo
ECOR
electroCore
$4.95
+1.0%
-6.8%
The price history of ECOR in the last 30 days
gammaCore nVNS Acute and preventive treatment of migraine in adolescents between 12 and 17 years of age 9/30/2025 - Publication electroCore, Inc. announced the publication of a peer-reviewed study in Frontiers in Neurology demon…
Full Summary
Natera, Inc. stock logo
NTRA
Natera
$160.97
-1.3%
-4.3%
The price history of NTRA in the last 30 days
Signatera MRD Test for cancer therapies 9/30/2025 - Publication Natera, Inc announcedthe publication of a peer-reviewed manuscript in the Journal of Clinical Oncol…
Full Summary
AbbVie Inc. stock logo
ABBV
AbbVie
$231.47
+3.7%
+10.1%
The price history of ABBV in the last 30 days
CADENZA Treat Rare Cancer with Limited Treatment Options BLA 9/30/2025 - BLA Filing AbbVie announced submission of a new Biologics License Application (BLA) to the U.S. Food and Drug A…
Full Summary
Lipocine Inc. stock logo
LPCN
Lipocine
$2.85
+1.4%
-2.1%
The price history of LPCN in the last 30 days
LPCN 1154 Postpartum depression (PPD)
Phase 3
9/30/2025 - Provided Update Lipocine Inc today provided an update on its ongoing pivotal Phase 3 clinical trial evaluating LPCN …
Full Summary
Lipocine Inc. stock logo
LPCN
Lipocine
$2.85
+1.4%
-2.1%
The price history of LPCN in the last 30 days
LPCN 1154 Postpartum depression (PPD) Target date: Q2 2026 9/30/2025 - Top-line results Lipocine Inc announced that The study is progressing on track with one-third of planned patients ra…
Full Summary
Cellectar Biosciences, Inc. stock logo
CLRB
Cellectar Biosciences
$5.60
+3.5%
+15.0%
The price history of CLRB in the last 30 days
Iopofosine I-131 Pediatric Brain and Solid Tumors 9/30/2025 - Provided Update Cellectar Biosciences, announced that Jarrod Longcor, chief operating officer of Cellectar, delivere…
Full Summary
SELLAS Life Sciences Group, Inc. stock logo
SLS
SELLAS Life Sciences Group
$1.61
+3.2%
-16.1%
The price history of SLS in the last 30 days
SLS009 For Treatment of Acute Myeloid Leukemia 9/30/2025 - Provided Update SELLAS Life Sciences Group, announced that it will host a virtual R&D Day on Wednesday, October 29, …
Full Summary
PolyPid Ltd. stock logo
PYPD
PolyPid
$3.34
+0.3%
-0.3%
The price history of PYPD in the last 30 days
D-PLEX100 Surgical Site Infections in Colorectal Surgery 9/30/2025 - Results PolyPid Ltd. announced that Dr. Shmuel Sharoni will present the topline results from the Company's s…
Full Summary
Savara Inc. stock logo
SVRA
Savara
$3.57
+1.4%
+8.8%
The price history of SVRA in the last 30 days
Molgramostim (IMPALA-2) Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
Phase 3
9/29/2025 - Analysis Savara Inc. announced additional analyses from its pivotal Phase 3 IMPALA-2 clinical trial of molgr…
Full Summary
PureTech Health PLC Sponsored ADR stock logo
PRTC
PureTech Health
$18.37
+1.8%
+7.6%
The price history of PRTC in the last 30 days
LYT-100-COV (deupirfenidone) Post-acute Long COVID with respiratory complications
Phase 2b
9/29/2025 - New Data PureTech Health plc announced new data from the open-label extension (OLE) of its Phase 2b ELEVAT…
Full Summary
AstraZeneca PLC stock logo
AZN
AstraZeneca
$76.72
+3.5%
-4.0%
The price history of AZN in the last 30 days
Enhertu (Trastuzumab deruxtecan) Untreated HER2 Mutant Metastatic Non-Small Cell Lung Cancer (NSCLC) 9/29/2025 - Positive Results AstraZeneca announced Positive high-level results from a planned interim analysis of the DESTINY-Bre…
Full Summary
Rapt Therapeutics stock logo
RAPT
Rapt Therapeutics
$25.79
-3.1%
+126.6%
The price history of RAPT in the last 30 days
RPT904 Food Allergy
NDA
9/29/2025 - FDA Clearance RAPT Therapeutics, Inc announced that the U.S. Food and Drug Administration (FDA) has cleared RAPT…
Full Summary
Enanta Pharmaceuticals, Inc. stock logo
ENTA
Enanta Pharmaceuticals
$11.97
-21.0%
+42.5%
The price history of ENTA in the last 30 days
zelicapavir For respiratory syncytial virus
Phase 2b
9/29/2025 - Top-line data Enanta Pharmaceuticals, Inc announced positive topline data from RSVHR, a Phase 2b, randomized, doub…
Full Summary
Larimar Therapeutics, Inc. stock logo
LRMR
Larimar Therapeutics
$3.23
-4.4%
-10.8%
The price history of LRMR in the last 30 days
nomlabofusp For Friedreich's Ataxia 9/29/2025 - Positive Data Larimar Therapeutics, announced positive 25 mg and 50 mg data from the ongoing long-term open label …
Full Summary
Tonix Pharmaceuticals Holding Corp. stock logo
TNXP
Tonix Pharmaceuticals
$24.16
-2.4%
-18.5%
The price history of TNXP in the last 30 days
TNX-2900 Prader-Willi Syndrome 9/29/2025 - Provided Update Tonix Pharmaceuticals announced plans to progress its TNX-2900 program for the treatment of Prader-…
Full Summary
Vor Biopharma Inc. stock logo
VOR
Vor Biopharma
$48.72
+22.1%
+23.7%
The price history of VOR in the last 30 days
telitacicept Sjögren's Disease
Phase 3
9/29/2025 - Clinical Data Vor Bio announced that clinical data from the Phase 3 study in China evaluating telitacicept in adul…
Full Summary
Applied Therapeutics Inc. stock logo
APLT
Applied Therapeutics
$0.60
-1.1%
+22.8%
The price history of APLT in the last 30 days
govorestat For the Treatment of Classic Galactosemia Target date: Q3 2025 9/29/2025 - FDA Meeting Applied Therapeutics, Inc. announced that the Company completed a meeting with the U.S. Food and Dr…
Full Summary
Climb Bio, Inc. stock logo
CLYM
Climb Bio
$2.01
+1.0%
-9.9%
The price history of CLYM in the last 30 days
CLYM116 for IgAN 9/29/2025 - Results Climb Bio, Inc. announced results from a completed nonhuman primate (NHP) study comparing CLYM116 t…
Full Summary
Cytosorbents Corporation stock logo
CTSO
Cytosorbents
$0.93
+0.9%
-1.0%
The price history of CTSO in the last 30 days
DrugSorb-ATR Antithrombotic Removal System 9/29/2025 - Provided Update CytoSorbents Corporation announced its strong scientific presence at the upcoming European Associati…
Full Summary
REGENXBIO Inc. stock logo
RGNX
REGENXBIO
$9.65
-2.0%
+8.1%
The price history of RGNX in the last 30 days
RGX-202 Duchenne Muscular Dystrophy 9/29/2025 - Presentation REGENXBIO Inc announced Chief Medical Officer, Steve Pakola, M.D., will present at the International…
Full Summary
Medicus Pharma Ltd stock logo
MDCX
Medicus Pharma
$2.32
-7.6%
+19.6%
The price history of MDCX in the last 30 days
SKNJCT-004 To Non-Invasively Treat Basal Cell Carcinoma of the Skin (BCC) FDA Type C Meeting 9/29/2025 - Positive Feedback Medicus Pharma Ltd is pleased to announce positive feedback from Type C meeting with United States…
Full Summary
Cytokinetics, Incorporated stock logo
CYTK
Cytokinetics
$54.96
+2.0%
+55.6%
The price history of CYTK in the last 30 days
Aficamten Symptomatic obstructive hypertrophic cardiomyopathy (oHCM) 9/29/2025 - Presentation Cytokinetics, Incorporated announced that additional data related to aficamten were presented in a L…
Full Summary
electroCore, Inc. stock logo
ECOR
electroCore
$4.95
+1.0%
-6.8%
The price history of ECOR in the last 30 days
gammaCore nVNS Acute and preventive treatment of migraine in adolescents between 12 and 17 years of age 9/29/2025 - Provided Update electroCore, Inc. announced that gammaCore™ Sapphire (nVNS) has been included in a long-term reimbu…
Full Summary
KALA BIO, Inc. stock logo
KALA
KALA BIO
$1.53
-25.4%
-86.4%
The price history of KALA in the last 30 days
KPI-012 Clinical diagnosis of PCED
Phase 2b
9/29/2025 - Endpoint Missed KALA BIO, Inc. announced that its CHASE (Corneal Healing After SEcretome therapy) Phase 2b clinical …
Full Summary
INmune Bio, Inc. stock logo
INMB
INmune Bio
$2.07
-1.9%
+2.0%
The price history of INMB in the last 30 days
XPro1595 Alzheimer’s disease
Phase 2
9/29/2025 - Provided Update INmune Bio, Inc. announces the submission of a manuscript detailing the results of its Phase 2 MINDF…
Full Summary
Johnson & Johnson stock logo
JNJ
Johnson & Johnson
$185.40
+2.1%
+4.7%
The price history of JNJ in the last 30 days
Guselkumab For Treatment Of Adults With Moderately To Severely Active Ulcerative Colitis 9/29/2025 - FDA approved Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved TREMFYA® (…
Full Summary
Candel Therapeutics, Inc. stock logo
CADL
Candel Therapeutics
$5.10
-5.6%
-11.9%
The price history of CADL in the last 30 days
CAN-2409 Prostate cancer
Phase 3
9/29/2025 - Analysis Candel Therapeutics, Inc presented subgroup analyses focused on the radiation regimen from the Comp…
Full Summary
NRx Pharmaceuticals, Inc. stock logo
NRXP
NRx Pharmaceuticals
$3.30
+1.5%
+42.2%
The price history of NRXP in the last 30 days
KETAFREE™ preservative-free ketamine product ANDA 9/29/2025 - re-filing NRx Pharmaceuticals, announced the re-filing of its Abbreviated New Drug Application (ANDA) to the U…
Full Summary
Oncobiologics, Inc. stock logo
OTLK
Oncobiologics
$1.06
+24.5%
The price history of OTLK in the last 30 days
ONS-5010 / LYTENAVA (Bevacizumab-vikg) Wet age-related macular degeneration (wet AMD) FDA Type C Meeting 9/29/2025 - FDA Meeting - Outlook Therapeutics, Inc y announced that it has completed the Type A Meeting with the U.S. Food…
Full Summary
Candel Therapeutics, Inc. stock logo
CADL
Candel Therapeutics
$5.10
-5.6%
-11.9%
The price history of CADL in the last 30 days
CAN-2409 Prostate cancer 9/29/2025 - Presentation Candel Therapeutics, Inc. presented subgroup analyses focused on the radiation regimen from the Comp…
Full Summary
Guardant Health, Inc. stock logo
GH
Guardant Health
$62.48
+0.8%
-7.3%
The price history of GH in the last 30 days
Guardant360 Advanced solid tumors. 9/29/2025 - FDA approved Guardant Health, Inc announced that the U.S. Food and Drug Administration (FDA) has approved its Gu…
Full Summary
NovoCure Limited stock logo
NVCR
NovoCure
$12.92
+4.8%
The price history of NVCR in the last 30 days
Tumor Treating Fields - METIS Brain metastases
Phase 3
9/29/2025 - Results Novocure nnounced that final results from the Phase 3 METIS trial of Tumor Treating Fields (TTFields…
Full Summary
Nanobiotix S.A. Sponsored ADR stock logo
NBTX
Nanobiotix
$18.89
+4.8%
+111.3%
The price history of NBTX in the last 30 days
JNJ-1900 for patients with cancer 9/29/2025 - Updated data NANOBIOTIX announced updated data from cohorts 1 and 2 of Study 1100, a multicenter Phase 1 dose esc…
Full Summary
Eupraxia Pharmaceuticals Inc. stock logo
EPRX
Eupraxia Pharmaceuticals
$5.90
+2.6%
+10.1%
The price history of EPRX in the last 30 days
EP-104GI For Treatment of Eosinophilic Esophagitis 9/29/2025 - Provided Update Eupraxia Pharmaceuticals Inc today provided an operational update on the development of EP-104GI, …
Full Summary
Strategy Inc stock logo
MSTR
Strategy
$322.57
-1.2%
-3.5%
The price history of MSTR in the last 30 days
MET-097i GLP-1 RA Candidate
Phase 2b
9/29/2025 - Top-line data Metsera, Inc announced positive topline data from VESPER-1 and positive data from a planned interim…
Full Summary
Kura Oncology, Inc. stock logo
KURA
Kura Oncology
$8.85
-1.3%
+12.0%
The price history of KURA in the last 30 days
Ziftomenib Treatment of genetically defined AML patients with high unmet need 9/29/2025 - Dose Update Kura Oncology, announced that the first patient has been dosed under the KOMET-017 clinical trial pr…
Full Summary
Liquidia Technologies, Inc. stock logo
LQDA
Liquidia Technologies
$22.74
-0.3%
-17.8%
The price history of LQDA in the last 30 days
LIQ861 (Treprostinil) Pulmonary arterial hypertension (PAH) 9/29/2025 - Oral presentation Liquidia Corporation announced today the company will present two oral presentations at the CHEST 2…
Full Summary
Connect Biopharma Holdings Limited Sponsored ADR stock logo
CNTB
Connect Biopharma
$1.51
+14.6%
-26.7%
The price history of CNTB in the last 30 days
IL-4Rα For asthma 9/29/2025 - Data Presentation Connect Biopharma Holdings today presented data supporting rademikibart, the Company's investigatio…
Full Summary
CorMedix Inc stock logo
CRMD
CorMedix
$11.63
-1.9%
-21.6%
The price history of CRMD in the last 30 days
REZZAYO in the prevention of Candida, Aspergillus, and Pneumocystis infection in patients undergoing allogeneic blood and marrow transplantation (BMT). Target date: Q2 2026 9/29/2025 - Top-line results CorMedix Inc. announced that Topline Results from ReSPECT Study Expected in 2Q 2026
Full Summary
CorMedix Inc stock logo
CRMD
CorMedix
$11.63
-1.9%
-21.6%
The price history of CRMD in the last 30 days
REZZAYO in the prevention of Candida, Aspergillus, and Pneumocystis infection in patients undergoing allogeneic blood and marrow transplantation (BMT).
Phase 3
9/29/2025 - Enrollment Completion CorMedix Inc.announced completion of enrollment for the ongoing, global Phase III ReSPECT trial eval…
Full Summary
Alnylam Pharmaceuticals, Inc. stock logo
ALNY
Alnylam Pharmaceuticals
$456.00
+1.9%
+2.1%
The price history of ALNY in the last 30 days
Vutrisiran (HELIOS-B) Transthyretin-Mediated (ATTR) Amyloidosis with Cardiomyopathy
Phase 3
9/28/2025 - Results Alnylam Pharmaceuticals today announced results from new analyses of the HELIOS-B Phase 3 study of …
Full Summary
Biogen Inc. stock logo
BIIB
Biogen
$140.08
+1.1%
+5.9%
The price history of BIIB in the last 30 days
LEQEMBI® (lecanemab-irmb) Treatment of Alzheimer's Disease 9/28/2025 - Provided Update Eisai Co., and Biogen Inc. announced that humanized anti-soluble aggregated amyloid-beta (Aβ) monoc…
Full Summary
Larimar Therapeutics, Inc. stock logo
LRMR
Larimar Therapeutics
$3.23
-4.4%
-10.8%
The price history of LRMR in the last 30 days
nomlabofusp For Friedreich's Ataxia 9/28/2025 - Provided Update Larimar Therapeutics, announced that the Company will host a conference call and webcast to discuss …
Full Summary
Incyte Corporation stock logo
INCY
Incyte
$84.81
+1.1%
+0.2%
The price history of INCY in the last 30 days
ruxolitinib cream Atopic dermatitis (AD), a type of eczema
Phase 3
9/28/2025 - Positive Results China Medical System Holdings Limited ("CMS") is pleased to announce that its subsidiaries, Dermavon…
Full Summary
Mesoblast Limited stock logo
MESO
Mesoblast
$16.11
+0.6%
+16.5%
The price history of MESO in the last 30 days
RYONCIL For the treatment of severe and life-threatening inflammatory conditions. 9/26/2025 - Provided Update Mesoblast Limited today reiterated that its allogeneic cell therapy products are manufactured from …
Full Summary
KalVista Pharmaceuticals, Inc. stock logo
KALV
KalVista Pharmaceuticals
$12.18
-0.2%
-9.5%
The price history of KALV in the last 30 days
sebetralstat Therapy for hereditary angioedema (HAE). 9/26/2025 - Presentation KalVista Pharmaceuticals, Inc announced the acceptance of six abstracts for ePoster presentation at…
Full Summary
Regeneron Pharmaceuticals, Inc. stock logo
REGN
Regeneron Pharmaceuticals
$562.27
+0.3%
-3.2%
The price history of REGN in the last 30 days
Evkeeza treatment of children from age 1 to less than 5 years old with homozygous familial hypercholesterolemia (HoFH). 9/26/2025 - FDA Meeting Request Regeneron Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved E…
Full Summary
AbbVie Inc. stock logo
ABBV
AbbVie
$231.47
+3.7%
+10.1%
The price history of ABBV in the last 30 days
Tavapadon Parkinson’s disease
NDA
9/26/2025 - NDA Filing AbbVie announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Admini…
Full Summary
Tiziana Life Sciences Ltd stock logo
TLSA
Tiziana Life Sciences
$2.16
+1.4%
+19.3%
The price history of TLSA in the last 30 days
ECTRIMS Pathogenesis of neuroinflammatory diseases 9/25/2025 - Presentation Immunic, Inc announced the presentation of key data in an oral and four poster presentations, includ…
Full Summary
Merck & Co., Inc. stock logo
MRK
Merck & Co., Inc.
$83.96
+6.8%
-0.2%
The price history of MRK in the last 30 days
EV-303 For Certain Patients with Muscle-Invasive Bladder Cancer 9/25/2025 - Highlights Pfizer Inc will highlight data across its extensive Oncology portfolio at the European Society for M…
Full Summary
Bristol Myers Squibb Company stock logo
BMY
Bristol Myers Squibb
$45.00
+1.9%
-4.6%
The price history of BMY in the last 30 days
Deucravacitinib Moderate to severe plaque psoriasis 9/25/2025 - Expansion Bristol Myers Squibb announced an expansion of its direct-to-patient offerings, providing eligible …
Full Summary
AC Immune stock logo
ACIU
AC Immune
$2.89
-4.9%
+41.7%
The price history of ACIU in the last 30 days
ACI-35.030 Alzheimer’s Disease (AD) 9/25/2025 - Publication AC Immune SA announced the peer-reviewed publication in eBioMedicine of results from the completed P…
Full Summary
Leap Therapeutics, Inc. stock logo
LPTX
Leap Therapeutics
$0.45
+26.2%
+57.4%
The price history of LPTX in the last 30 days
DKN-01 Advanced gynecological malignancies 9/25/2025 - Results Leap Therapeutics, Inc announced it will present the final clinical results from Part B of the DeF…
Full Summary
Capricor Therapeutics, Inc. stock logo
CAPR
Capricor Therapeutics
$7.21
-2.7%
+14.8%
The price history of CAPR in the last 30 days
deramiocel For the treatment of Duchenne muscular dystrophy (DMD) BLA 9/25/2025 - Provided Update Capricor Therapeutics announced a regulatory update for its Biologics License Application (BLA) for …
Full Summary
MediWound Ltd. stock logo
MDWD
MediWound
$18.02
+0.3%
+7.9%
The price history of MDWD in the last 30 days
NexoBrid Enzymatically removes nonviable burn tissue Australian TGA Approval 9/25/2025 - Marketing authorization MediWound Ltd. announced that Australia's Therapeutic Goods Administration (TGA) has granted marketi…
Full Summary
Vericel Corporation stock logo
VCEL
Vericel
$31.47
-1.0%
-13.4%
The price history of VCEL in the last 30 days
NexoBrid Enzymatically removes nonviable burn tissue Australian TGA Approval 9/25/2025 - Marketing authorization MediWound Ltd. announced that Australia's Therapeutic Goods Administration (TGA) has granted marketi…
Full Summary
Anebulo Pharmaceuticals, Inc. stock logo
ANEB
Anebulo Pharmaceuticals
$2.50
+3.3%
Selonabant for Acute Cannabis-Induced Toxicity
Phase 1
9/25/2025 - Dose Update Anebulo Pharmaceuticals, Inc announces the first subjects dosed in its Phase 1 single ascending dos…
Full Summary
Vertex Pharmaceuticals Incorporated stock logo
VRTX
Vertex Pharmaceuticals
$391.64
-0.9%
+0.2%
The price history of VRTX in the last 30 days
inaxaplin APOL1-mediated kidney disease 9/25/2025 - Provided Update Vertex Pharmaceuticals Incorporated announced several important advancements across its programs i…
Full Summary
Vanda Pharmaceuticals Inc. stock logo
VNDA
Vanda Pharmaceuticals
$4.99
+1.6%
+5.5%
The price history of VNDA in the last 30 days
HETLIOZ For treat jet lag disorder 9/25/2025 - Publication Vanda Pharmaceuticals Inc. announced the publication of an article titled "Melatonin agonist tasime…
Full Summary
Tiziana Life Sciences Ltd stock logo
TLSA
Tiziana Life Sciences
$2.16
+1.4%
+19.3%
The price history of TLSA in the last 30 days
TZLS-501 A Fully Human anti-IL-6 receptor Monoclonal Antibody 9/25/2025 - Provided Update Tiziana Life Sciences, Ltd announces it will advance its second asset, a fully human anti-IL-6 recep…
Full Summary
Intellia Therapeutics, Inc. stock logo
NTLA
Intellia Therapeutics
$17.27
+2.1%
+52.2%
The price history of NTLA in the last 30 days
nex-z For Transthyretin (ATTR) Amyloidosis with Polyneuropathy 9/25/2025 - Data Intellia Therapeutics, announced longer-term follow-up data from the ongoing Phase 1 study of invest…
Full Summary
Eli Lilly and Company stock logo
LLY
Eli Lilly and Company
$763.01
+5.0%
+4.2%
The price history of LLY in the last 30 days
Imlunestrant oral selective estrogen receptor degrader 9/25/2025 - FDA approved Eli Lilly and Company announced today that the U.S. Food and Drug Administration (FDA) has approved …
Full Summary
Sanofi stock logo
SNY
Sanofi
$47.20
+3.4%
-4.6%
The price history of SNY in the last 30 days
vandetanib thyroid cancer treatment 9/25/2025 - Provided Update Sanofi SA announced that The U.S. Food and Drug Administration today removed the Risk Evaluation an…
Full Summary
Cidara Therapeutics, Inc. stock logo
CDTX
Cidara Therapeutics
$95.76
+0.5%
+46.4%
The price history of CDTX in the last 30 days
CD388 Universal Prevention and Treatment of Influenza
Phase 3
9/25/2025 - Dosing Update Cidara Therapeutics, Inc announced that the first participants have been dosed in its Phase 3 trial …
Full Summary
Kura Oncology, Inc. stock logo
KURA
Kura Oncology
$8.85
-1.3%
+12.0%
The price history of KURA in the last 30 days
Ziftomenib Treatment of genetically defined AML patients with high unmet need 9/25/2025 - Publication Kura Oncology, announced the Journal of Clinical Oncology published the full results from the pivota…
Full Summary
Organogenesis stock logo
ORGO
Organogenesis
$4.22
-0.9%
-18.1%
The price history of ORGO in the last 30 days
ReNu for Knee Osteoarthritis
Phase 3
9/25/2025 - Endpoint Missed Organogenesis Holdings announced that the second Phase 3 randomized controlled trial (RCT) of ReNu, …
Full Summary
Zimmer Biomet Holdings, Inc. stock logo
ZBH
Zimmer Biomet
$98.49
+0.2%
-7.2%
The price history of ZBH in the last 30 days
iTaperloc First Iodine-Treated Total Hip Replacement System Japanese Pharmaceuticals and Medical Devices Agency (PMDA) Approval 9/25/2025 - Approved Zimmer Biomet Holdings announced the Pharmaceutical and Medical Devices Agency (PMDA) in Japan appr…
Full Summary
Quince Therapeutics, Inc. stock logo
QNCX
Quince Therapeutics
$1.63
+1.2%
+1.9%
The price history of QNCX in the last 30 days
eDSP For Treatment Of Rare Neurodegenerative Disease Ataxia-Telangiectasia
Phase 3
9/25/2025 - Publication Quince Therapeutics, Inc. announced the publication of an advanced population pharmacokinetic (PK)…
Full Summary
Crinetics Pharmaceuticals, Inc. stock logo
CRNX
Crinetics Pharmaceuticals
$41.65
-4.3%
+34.4%
The price history of CRNX in the last 30 days
Paltusotine Acromegaly 9/25/2025 - FDA approved Crinetics Pharmaceuticals, announced that the U.S. Food and Drug Administration (FDA) approved PALSO…
Full Summary
Eli Lilly and Company stock logo
LLY
Eli Lilly and Company
$763.01
+5.0%
+4.2%
The price history of LLY in the last 30 days
Donanemab Alzheimer's disease (AD) European Commission 9/25/2025 - Marketing authorization Eli Lilly and Company announced today that the European Commission (EC) has granted marketing autho…
Full Summary
AstraZeneca PLC stock logo
AZN
AstraZeneca
$76.72
+3.5%
-4.0%
The price history of AZN in the last 30 days
ENHERTU® (fam-trastuzumab deruxtecan-nxki) For the treatment of adult patients with unresectable or metastatic HER2 positive sBLA Priority Review 9/24/2025 - FDA Accepted AstraZeneca and Daiichi Sankyo announced that supplemental Biologics License Application (sBLA) fo…
Full Summary
Burning Rock Biotech Limited Sponsored ADR stock logo
BNR
Burning Rock Biotech
$8.65
-7.9%
+1.1%
The price history of BNR in the last 30 days
Capivasertib in Breast Cancer MHLW Approval 9/24/2025 - Approved Riken Genesis Co., Ltd. and Burning Rock Biotech Limited announced that the OncoGuide™ OncoScreen™ P…
Full Summary
Cidara Therapeutics, Inc. stock logo
CDTX
Cidara Therapeutics
$95.76
+0.5%
+46.4%
The price history of CDTX in the last 30 days
CD388 Universal Prevention and Treatment of Influenza
Phase 3
9/24/2025 - Provided Update Cidara Therapeutics, Inc. announced updates to its planned Phase 3 registrational trial of CD388 fo…
Full Summary
FibroGen, Inc stock logo
FGEN
FibroGen
$12.25
-0.5%
+3.6%
The price history of FGEN in the last 30 days
FG-3246 In Patients with Metastatic Castration-Resistant Prostate Cancer
Phase 2
9/24/2025 - Initiation FibroGen, announced the initiation of the Phase 2 monotherapy, dose-optimization trial of FG-3246, a…
Full Summary
ACADIA Pharmaceuticals Inc. stock logo
ACAD
ACADIA Pharmaceuticals
$21.34
+0.1%
-17.9%
The price history of ACAD in the last 30 days
ACP-101 For the treatment of hyperphagia in Prader-Willi syndrome (PWS).
Phase 3
9/24/2025 - Top-line results Acadia Pharmaceuticals Inc. announced top-line results from the Phase 3 COMPASS PWS trial evaluati…
Full Summary
Summit Therapeutics PLC stock logo
SMMT
Summit Therapeutics
$20.66
-2.4%
-12.8%
The price history of SMMT in the last 30 days
Ivonescimab For Lung cancer
Phase 3
9/24/2025 - Data Summit Therapeutics Inc announced that data from the Phase III HARMONi-6 trial, conducted in China…
Full Summary
Biogen Inc. stock logo
BIIB
Biogen
$140.08
+1.1%
+5.9%
The price history of BIIB in the last 30 days
Lecanemab (BAN2401) Anti-amyloid beta (Aβ) protofibril antibody for the treatment of Alzheimer's disease (AD) Australian TGA Approval 9/24/2025 - Approved Eisai Co. and Biogen Inc. announced that the Therapeutic Goods Administration (TGA) of Australia has…
Full Summary
Envoy Medical, Inc. stock logo
COCH
Envoy Medical
$0.78
-3.0%
-36.9%
The price history of COCH in the last 30 days
Acclaim for Breakthrough Hearing Device 9/24/2025 - Provided Update Envoy Medical® Inc announced it is scaling its commercialization planning for the company's breakthr…
Full Summary
NRx Pharmaceuticals, Inc. stock logo
NRXP
NRx Pharmaceuticals
$3.30
+1.5%
+42.2%
The price history of NRXP in the last 30 days
KETAFREE™ preservative-free ketamine product 9/24/2025 - Provided Update NRx Pharmaceuticals, announced that it was notified yesterday by the United States Food and Drug Ad…
Full Summary
Harmony Biosciences Holdings, Inc. stock logo
HRMY
Harmony Biosciences
$27.56
-0.3%
-25.3%
The price history of HRMY in the last 30 days
ZYN002 In Fragile X Syndrome
Phase 3
9/24/2025 - Top-line results Harmony Biosciences Holdings, Inc announced topline results from its Phase 3 registrational clinica…
Full Summary
Cellectar Biosciences, Inc. stock logo
CLRB
Cellectar Biosciences
$5.60
+3.5%
+15.0%
The price history of CLRB in the last 30 days
CLR 125 For the treatment of relapsed TNBC.
Phase 1b
9/24/2025 - Provided Update Cellectar Biosciences, Inc. have entered into an agreement whereby Evestia will provide Cellectar w…
Full Summary
Akari Therapeutics PLC stock logo
AKTX
Akari Therapeutics
$1.01
-1.1%
+32.9%
The price history of AKTX in the last 30 days
AR-V7 for the treatment of tumors fueled by alternative splicing-drivers, such as the Androgen Receptor splice variant 7 (AR-V7) in prostate cancer. 9/24/2025 - Preclinical Data Akari Therapeutics announced key preclinical data demonstrating the potential of its novel antibody…
Full Summary
Sanofi stock logo
SNY
Sanofi
$47.20
+3.4%
-4.6%
The price history of SNY in the last 30 days
SAR446268 for the treatment of non-congenital myotonic dystrophy type 1
Fast Track
9/23/2025 - Designation Grant Sanofi announced that The US Food and Drug Administration (FDA) has granted fast track designation …
Full Summary
AbbVie Inc. stock logo
ABBV
AbbVie
$231.47
+3.7%
+10.1%
The price history of ABBV in the last 30 days
SKINVIVE Advancing Global Skin Quality 9/23/2025 - Roll Out Allergan Aesthetics, an AbbVie company announced the roll-out of SKINVIVE by JUVÉDERM® in 35 additi…
Full Summary
Bristol Myers Squibb Company stock logo
BMY
Bristol Myers Squibb
$45.00
+1.9%
-4.6%
The price history of BMY in the last 30 days
iberdomide Relapsed or Refractory Multiple Myeloma
Phase 3
9/23/2025 - evaluation Bristol Myers Squibb announced that the Phase 3 EXCALIBER-RRMM study evaluating iberdomide, an inve…
Full Summary
Elanco Animal Health Incorporated stock logo
ELAN
Elanco Animal Health
$20.16
+2.8%
+9.7%
The price history of ELAN in the last 30 days
Zenrelia Treatment for canine allergic itch and inflammation 9/23/2025 - Provided Update Elanco Animal Health nnounced important updates to the U.S. Zenrelia label, following the Food and …
Full Summary
Seres Therapeutics, Inc. stock logo
MCRB
Seres Therapeutics
$19.24
+2.9%
+1.6%
The price history of MCRB in the last 30 days
SER-155 Prevention of Antibiotic-Resistant Bacterial Infections and Graft-versus-Host Disease (GvHD)
Phase 2
9/23/2025 - Feedback Seres Therapeutics, announced receipt of additional constructive feedback from the U.S. Food and Dr…
Full Summary
atai Life Sciences N.V. stock logo
ATAI
atai Life Sciences
$5.29
-2.9%
+15.5%
The price history of ATAI in the last 30 days
BPL-003 In Patients With Treatment Resistant Depression 9/23/2025 - Positive Data atai Life Sciences announced positive data from a proof-of-concept study investigating a two-dose in…
Full Summary
Scholar Rock Holding Corporation stock logo
SRRK
Scholar Rock
$37.24
-2.9%
+14.1%
The price history of SRRK in the last 30 days
Apitegromab Type 2 and Type 3 Spinal Muscular Atrophy (SMA) 9/23/2025 - Complete Response Letter Scholar Rock announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Respo…
Full Summary
Moderna, Inc. stock logo
MRNA
Moderna
$25.83
+2.0%
+7.2%
The price history of MRNA in the last 30 days
COVID-19 vaccine Covid-19 9/23/2025 - Positive Data Moderna, Inc. announced positive preliminary immunogenicity data for the 2025-2026 formula of mNEXS…
Full Summary
Sensei Biotherapeutics, Inc. stock logo
SNSE
Sensei Biotherapeutics
$9.45
-1.0%
+17.0%
The price history of SNSE in the last 30 days
Solnerstotug in PD-(L)1 Resistant Tumors 9/23/2025 - Provided Update Sensei Biotherapeutics, Inc. announced that it will host a virtual key opinion leader (KOL) event on…
Full Summary

Frequently Asked Questions

This calendar tracks PDUFA target dates, NDA/BLA submissions and reviews, regulatory meeting outcomes, early-phase trial results, and special designations such as RMAT, Breakthrough Therapy, or orphan status.

The PDUFA date (Prescription Drug User Fee Act) is the FDA’s target deadline to approve or reject a New Drug Application (NDA) or Biologics License Application (BLA). These are major catalysts for biotech stocks, as a decision often triggers significant price movement.

What does the Status column indicate?

This column shows the current stage or outcome of the FDA-related event listed, such as PDUFA Target Date Set, CRL Issued, Approved, or Designation Granted. It gives you a quick snapshot of where the drug is in the regulatory process and what action has occurred (or is expected).

Phase 1: Focuses on safety and dosage in a small group of healthy volunteers.

Phase 2: Explores effectiveness and side effects in a larger patient group.

Phase 3: Confirms effectiveness, monitors side effects, and compares with standard treatments in large populations. This is usually the last step before FDA submission.

Submission means the company has filed an NDA or BLA with the FDA. Review is the FDA’s evaluation period leading up to the PDUFA date. Approval indicates the FDA has given the green light to market the drug.

A grant refers to an award of a designation (i.e., RMAT), while a target date usually refers to a PDUFA date (the FDA’s deadline to act on an NDA or BLA).

Special FDA designations are programs designed to expedite the development and review of promising therapies. Breakthrough Therapy designation is granted to drugs that may offer substantial improvement over existing treatments for serious conditions. Orphan Drug designation is awarded to treatments targeting rare diseases affecting fewer than 200,000 people in the U.S. Other fast-track designations include RMAT (Regenerative Medicine Advanced Therapy), Fast Track, and Accelerated Approval.

Yes, you can export the data to Excel for further sorting, filtering, or integration into personal analytics tools.

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process