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.

On This Page: Legend for FDA Event Status Abbreviations Resources FAQ

Main Company	Current Price	30-Day Price Change	Drug	Status	Event
PRTC PureTech Health	$18.53 +0.9%	+1.6%	LYT-100 Idiopathic Pulmonary Fibrosis		8/21/2025 - Provided Update PureTech Health plc demonstrated its growing leadership in idiopathic pulmonary fibrosis (IPF) at t… Full Summary
DVAX Dynavax Technologies	$10.95 +5.1%	-2.1%	Z-1018 Shingles Vaccine Profile	Phase 1/2	8/21/2025 - Top-line results Dynavax Technologies announced positive topline results from Part 1 of its randomized, observer-bli… Full Summary
CRNX Crinetics Pharmaceuticals	$29.40 +1.1%	-3.5%	Atumelnant In Congenital Adrenal Hyperplasia (CAH)	Orphan Drug	8/21/2025 - Designation Grant Crinetics Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) granted … Full Summary
ABBV AbbVie	$209.54 +0.2%	+12.0%	RINVOQ (upadacitinib) Moderate to Severe Atopic Dermatitis		8/21/2025 - Top-line results AbbVie announced positive topline results from the second of two pivotal studies of the Phase 3 UP-A… Full Summary
REGN Regeneron Pharmaceuticals	$598.16 +1.2%	+6.6%	EYLEA (aflibercept) Wet age-related macular degeneration (wet AMD)	EC Approval	8/21/2025 - Approved Alvotech announced that the European Commission has approved Mynzepli® as a biosimilar to Eylea® (af… Full Summary
SEPN Septerna	$11.70 +5.5%	-6.2%	SEP-631 For Mast Cell Diseases	Phase 1	8/21/2025 - Dosing Update Septerna, announced the dosing of the first participants in its Phase 1 clinical trial of SEP-631, a… Full Summary
NVCR NovoCure	$11.91 +1.1%	-26.9%	Tumor Treating Fields - PANOVA-3 Locally advanced pancreatic cancer		8/20/2025 - Application Submitted Novocure announced it submitted a premarket approval (PMA) application to the U.S. Food and Drug Adm… Full Summary
PFE Pfizer	$25.71 +1.3%	+2.3%	PAXLOVID Covid-19		8/20/2025 - Provided Update Enanta Pharmaceuticals, Inc announced today that it has filed suit in the Unified Patent Court (UP… Full Summary
SVRA Savara	$3.05 -1.3%	+26.6%	Molgramostim (IMPALA-2) Autoimmune Pulmonary Alveolar Proteinosis (aPAP)	Phase 2	8/20/2025 - Results Savara Inc. announced that the results from the Phase 3 IMPALA-2 clinical trial will be published on… Full Summary
RCKT Rocket Pharmaceuticals	$3.73 -0.5%	+10.7%	RP-A501 Danon Disease		8/20/2025 - Lifted Clinical Hold Rocket Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has lifted t… Full Summary
RYTM Rhythm Pharmaceuticals	$101.68 +3.0%	+15.8%	Setmelanotide (HO) Hypothalamic Obesity	supplemental New Drug Application (sNDA)	8/20/2025 - FDA Accepted Rhythm Pharmaceuticals, Inc announced that the U.S. Food and Drug Administration (FDA) has accepted… Full Summary
EOLS Evolus	$7.43 +2.8%	-22.4%	Evolysse™ Evolus dermal filler,		8/20/2025 - Application Submitted Evolus, Inc. announced that it has submitted the final module of its Premarket Approval (PMA) applic… Full Summary
CTSO Cytosorbents	$0.84 -5.6%	-15.6%	DrugSorb-ATR Antithrombotic Removal System		8/20/2025 - Regulatory Update CytoSorbents Corporation updates the regulatory status of its appeal with the U.S. Food and Drug Ad… Full Summary
BMY Bristol Myers Squibb	$48.38 +0.2%	+0.7%	Opdivo (nivolumab) Resected esophageal or gastroesophageal junction (GEJ) cancer in the adjuvant setting		8/20/2025 - FDA Approval Agilent Technologies Inc. announced that its MMR IHC Panel pharmDx (Dako Omnis) has received FDA app… Full Summary
CLDX Celldex Therapeutics	$22.02 +5.4%	-1.5%	Barzolvolimab For Prurigo Nodularis	Phase 2	8/19/2025 - Top-line results Celldex Therapeutics, Inc today reported topline results from the Company's ongoing Phase 2 study o… Full Summary
ALXO ALX Oncology	$1.03 +23.8%	+114.6%	ALX2004 For the treatment of epidermal growth factor receptor (EGFR)-expressing solid tumors		8/19/2025 - Dose Update ALX Oncology Holdings Inc announced that the first patient has been dosed in the Company's Phase 1 … Full Summary
BTAI BioXcel Therapeutics	$5.23 +3.8%	+189.8%	BXCL501 (SERENITY) Schizophrenia and bipolar disorders	Phase 3	8/19/2025 - Provided Update BioXcel Therapeutics announced completion of the database lock for its SERENITY At-Home pivotal Pha… Full Summary
MIRA MIRA Pharmaceuticals	$1.40 -1.4%	-20.0%	Ketamir-2 To treat depression and treatment-resistant depression (TRD).	Phase 1	8/19/2025 - Dose Update MIRA Pharmaceuticals, Inc. announced the successful completion of the Single Ascending Dose (SAD) p… Full Summary
VKTX Viking Therapeutics	$25.66 -0.1%	-20.1%	VK2735 Metabolic disorders	Phase 2	8/19/2025 - Top-line results Viking Therapeutics, Inc. announced positive top-line results from the company's Phase 2 clinical t… Full Summary
ALDX Aldeyra Therapeutics	$5.88 +4.4%	+9.7%	ADX-2191 Primary vitreoretinal lymphoma (PVRL)	Fast Track	8/19/2025 - Designation Grant Aldeyra Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted f… Full Summary
HCM HUTCHMED	$16.11 +1.4%	-8.9%	SANOVO for Certain Lung Cancer Patients	Phase 3	8/19/2025 - Enrollment Completion HUTCHMED (China) Limited announces the completion of patient enrollment of SANOVO, a China Phase II… Full Summary
ALT Altimmune	$3.53 -2.8%	-16.0%	pemvidutide for the treatment of obesity and MASH	Fast Track	8/19/2025 - Decision Deferred Altimmune, Inc announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track des… Full Summary
MDGL Madrigal Pharmaceuticals	$407.09 +3.9%	+29.9%	Rezdiffra (resmetirom) for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis.	European Commission Conditional Marketing Authorization	8/19/2025 - Marketing authorization Madrigal Pharmaceuticals, Inc announced that the European Commission (EC) has granted conditional m… Full Summary
DCTH Delcath Systems	$10.41 +0.8%	-6.0%	HEPZATO KIT For the treatment of metastatic uveal melanoma (mUM).	Phase 2	8/19/2025 - Dose Update Delcath Systems, Inc. announced that the first patient has been dosed at the City of Hope National … Full Summary
MREO Mereo BioPharma Group	$1.65 +1.2%	-6.3%	Vantictumab for Autosomal Dominant Osteopetrosis Type 2		8/19/2025 - Provided Update āshibio, a privately held, clinical-stage biotechnology company developing novel therapeutics for th… Full Summary
ALRN Aileron Therapeutics			LTI-03 In Idiopathic Pulmonary Fibrosis	Phase 2	8/19/2025 - Clinical Trial Rein Therapeutics announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) h… Full Summary
BTAI BioXcel Therapeutics	$5.23 +3.8%	+189.8%	BXCL501 (SERENITY) Schizophrenia and bipolar disorders	supplemental New Drug Application (sNDA)	8/18/2025 - Positive Opinion BioXcel Therapeutics, announced that it has received positive pre-sNDA meeting responses from the U… Full Summary
BMY Bristol Myers Squibb	$48.38 +0.2%	+0.7%	iza-bren For Patients with Previously Treated Advanced EGFR-Mutated Non-Small Cell Lung Cancer	Breakthrough Therapy	8/18/2025 - Designation Grant SystImmune Inc. and Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA)… Full Summary
VNDA Vanda Pharmaceuticals	$4.51 -2.0%	-4.2%	HETLIOZ For treat jet lag disorder		8/18/2025 - Regulatory Update Vanda Pharmaceuticals Inc. announced that it secured a landmark victory over the U.S. Food and Drug… Full Summary
SVRA Savara	$3.05 -1.3%	+26.6%	Molgramostim (IMPALA-2) Autoimmune Pulmonary Alveolar Proteinosis (aPAP)		8/18/2025 - FDA Accepted Savara Inc announced the acceptance of three abstracts for poster presentation at the European Resp… Full Summary
NTRA Natera	$161.95 +0.8%	+15.7%	IMvigor011 in Muscle-Invasive Bladder Cancer	Phase 3	8/18/2025 - Positive Results Natera, Inc. announced positive topline results from the randomized, phase III IMvigor011 clinical t… Full Summary
ENLV Enlivex Therapeutics	$1.03 -6.4%	-12.7%	Allocetra Sepsis		8/18/2025 - Top-line results Enlivex Announces Positive Topline Data From Multi-Country, Randomized, Controlled, Phase I/II Trial… Full Summary
PFE Pfizer	$25.71 +1.3%	+2.3%	PAXLOVID Covid-19	Phase 2	8/18/2025 - evaluation Traws Pharma, Inc. announced receipt from the Human Research Ethics Committee (HREC) of approval to… Full Summary
LH Labcorp	$276.51 -0.6%	+9.6%	Lumipulse® Blood Test for Alzheimer's Disease		8/18/2025 - Provided Update Labcorp announced today the availability of the Lumipulse® pTau-217/Beta Amyloid 42 Ratio, the first… Full Summary
SNGX Soligenix	$3.36 -6.9%	+138.3%	SGX945 In the Treatment of Aphthous Ulcers in Behçet's Disease	Orphan Drug	8/18/2025 - Designation Grant Soligenix, Inc. announced that the Office of Orphan Products Development of the United States (U.S.… Full Summary
RARE Ultragenyx Pharmaceutical	$29.52 +0.5%	+11.6%	DTX401 AAV For the Treatment of Glycogen Storage Disease Type Ia (GSDIa)	BLA Target date: Q4 2025	8/18/2025 - BLA Filing Ultragenyx Pharmaceutical announced that company has submitted the non-clinical and clinical modules… Full Summary
PSTV Plus Therapeutics	$0.48 -0.1%	+13.6%	REYOBIQ™ For Patients with Leptomeningeal Metastases	Phase 1	8/18/2025 - Positive Data Plus Therapeutics, Inc. announces positive data from the ReSPECT-LM Phase 1 single dose escalation … Full Summary
MMSI Merit Medical Systems	$86.63 -0.8%	+2.6%	WRAPSODY Cell-Impermeable Endoprosthesis (CIE).		8/18/2025 - Enrollment Update Merit Medical Systems announced today the successful enrollment of the first patient in the WRAP Nor… Full Summary
MRK Merck & Co., Inc.	$86.06 +1.7%	+5.3%	I-DXd In patients with pretreated extensive-stage small cell lung cancer (ES-SCLC).	Breakthrough Therapy	8/18/2025 - Designation Grant Daiichi Sankyo and Merck announced that Ifinatamab deruxtecan (I-DXd) has been granted Breakthrough… Full Summary
RDY Dr. Reddy's Laboratories	$14.40 +1.9%	-0.2%	Carac For the topical treatment of multiple actinic or solar keratoses of the face and anterior scalp.		8/18/2025 - Launch Extrovis AG, a global pharmaceutical company focused on research-driven innovation, and Dr. Reddy's … Full Summary
BTAI BioXcel Therapeutics	$5.23 +3.8%	+189.8%	BXCL501 (SERENITY) Schizophrenia and bipolar disorders	supplemental New Drug Application (sNDA) Target date: Q1 2026	8/18/2025 - sNDA Filing BioXcel Therapeutics, announced that sNDA submission on track for Q1 2026 Full Summary
RGNX REGENXBIO	$8.11 +0.5%	-5.4%	RGX-121 MPS II (Hunter Syndrome)	BLA	8/18/2025 - Provided Update REGENXBIO Inc. announced that the U.S. Food and Drug Administration (FDA) extended its review timeli… Full Summary
RARE Ultragenyx Pharmaceutical	$29.52 +0.5%	+11.6%	DTX401 AAV For the Treatment of Glycogen Storage Disease Type Ia (GSDIa)	BLA	8/18/2025 - rolling submission Ultragenyx Pharmaceutical announced the initiation of a rolling submission of a Biologics License A… Full Summary
NMTC NeuroOne Medical Technologies	$0.77 +2.4%	-25.3%	OneRF Ablation System for creation of radiofrequency ("RF") lesions in nervous tissue for functional neurosurgical procedures.		8/18/2025 - FDA Clearance NeuroOne Medical Technologies Corporation announced that it has received U.S. Food and Drug Adminis… Full Summary
CAPR Capricor Therapeutics	$7.01 -2.2%	+7.5%	StealthX exosome-based vaccine.	Phase 1	8/18/2025 - Dose Update Capricor Therapeutics announced that the first subjects have been dosed in a Phase 1 clinical trial… Full Summary
IOVA Iovance Biotherapeutics	$2.54 +0.4%	-18.8%	Lifileucel For the Treatment of Advanced Melanoma		8/18/2025 - Notice of Compliance Iovance Biotherapeutics, announced Health Canada has issued a Notice of Compliance with Conditions … Full Summary
IRD Opus Genetics	$1.15 -1.3%	-6.1%	OPGx-BEST1 For the treatment of bestrophin-1 (BEST1)-related IRD.	IND	8/18/2025 - FDA Accepted Opus Genetics announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigat… Full Summary
AAPG Ascentage Pharma Group International	$47.69 +1.0%	+21.1%	lisaftoclax In Venetoclax-Refractory Patients		8/17/2025 - FDA Clearance Ascentage Pharma announced that it has received clearance by the U.S. Food and Drug Administration … Full Summary
PGEN Precigen	$3.64 +13.4%	+139.5%	PAPZIMEOS For Treatment Of Adults With Recurrent Respiratory Papillomatosis		8/15/2025 - FDA approved Precigen, Inc. announced that the US Food and Drug Administration (FDA) has approved PAPZIMEOS™ (zo… Full Summary
GBT Global Blood Therapeutics	$68.49		Inclacumab + GBT601 Sickle Cell Disease	Phase 3	8/15/2025 - Results Pfizer Inc announced results from the Phase 3 THRIVE-131 study evaluating inclacumab, an investigati… Full Summary
TNXP Tonix Pharmaceuticals	$35.85 -0.6%	-19.9%	Tonmya For the management of fibromyalgia.		8/15/2025 - FDA approved Tonix Pharmaceuticals Holding Corp announced that the U.S. Food and Drug Administration (FDA) appro… Full Summary
NVO Novo Nordisk A/S	$55.46 +2.1%	-16.9%	Wegovy For cardiovascular risk reduction in adults with known heart disease and overweight or obesity		8/15/2025 - FDA approved Novo Nordisk announced that the US Food and Drug Administration (FDA) has approved a new indication … Full Summary
BIOA BioAge Labs	$4.50 +1.4%	-5.5%	BGE-102 For the treatment of obesity.	Phase 1	8/15/2025 - Dose Update BioAge Labs, Inc. announced that the first participant has been dosed in a Phase 1 clinical trial ev… Full Summary
VERU Veru	$3.55 +0.6%	-37.7%	Wegovy For cardiovascular risk reduction in adults with known heart disease and overweight or obesity		8/15/2025 - FDA approved Novo Nordisk announced that the US Food and Drug Administration (FDA) has approved a new indication … Full Summary
BEAM Beam Therapeutics	$16.01 -0.3%	-25.7%	BEAM-101 Sickle cell diseas	RMAT Designation	8/14/2025 - Designation Grant Beam Therapeutics Inc. announced that the United States (U.S.) Food and Drug Administration (FDA) … Full Summary
SMMT Summit Therapeutics	$26.01 +0.5%	-2.0%	Ivonescimab For Lung cancer	Phase 3	8/14/2025 - Data Summit Therapeutics Inc. announced that data from the Phase III HARMONi trial featuring the novel, … Full Summary
AKRO Akero Therapeutics	$48.29 +0.7%	-6.9%	Efruxifermin (HARMONY) Non-alcoholic steatohepatitis (NASH)		8/14/2025 - Publication Akero Therapeutics, Inc. announced publication of 96-week results from the Phase 2b HARMONY trial i… Full Summary
SRRK Scholar Rock	$34.59 +0.6%	-13.5%	Apitegromab Type 2 and Type 3 Spinal Muscular Atrophy (SMA)		8/14/2025 - Published Results Scholar Rock announced that positive study results from the pivotal Phase 3 SAPPHIRE trial (NCT05156… Full Summary
ATHA Athira Pharma	$0.39 -1.0%	-15.6%	ATH-1105 For Amyotrophic Lateral Sclerosis	Phase 1	8/14/2025 - presented results Athira Pharma, Inc. presented results from its Phase 1 clinical trial of ATH-1105 in healthy volunte… Full Summary
ENLV Enlivex Therapeutics	$1.03 -6.4%	-12.7%	Allocetra Sepsis	Phase 2a	8/14/2025 - Presentation Enlivex Therapeutics Ltd. announced it will host a webinar on Monday, August 18, 2025, at 8:00 AM … Full Summary
TLSA Tiziana Life Sciences	$1.93 +6.6%	+19.1%	Foralumab Crohn's disease with decreases in the classic side effects of cytokine release syndrome	Phase 2a	8/14/2025 - Enrollment Update Tiziana Life Sciences, Ltd. announced that the first participant has been enrolled and dosed in its… Full Summary
TRIB Trinity Biotech	$1.56 -10.3%	+116.7%	PreClara Preeclampsia Testing Service	Target date: Q3 2025	8/14/2025 - Regulatory Update Trinity Biotech plc announced that this week its New York, reference laboratory has received regula… Full Summary
MDWD MediWound	$17.39 -0.3%	-15.1%	EscharEx Chronic Wounds		8/13/2025 - Publication MediWound Ltd. announced the publication of "The Correlation Between Wound Bed Preparation and Woun… Full Summary
NUVL Nuvalent	$73.65 +0.6%	-8.7%	zidesamtinib ALK-selective inhibitor, neladalkib, and novel ROS1-selective inhibitor, zidesamtinib	Phase 1/2	8/13/2025 - Data Nuvalent, Inc. announced that pivotal data for zidesamtinib, a novel ROS1-selective inhibitor, in TK… Full Summary
CTMX CytomX Therapeutics	$2.03 +3.0%	-15.1%	CX-2051 A Probody® Antibody Drug Conjugate (ADC)	Phase 1	8/13/2025 - Provided Update CytomX Therapeutics, Inc provided an update on the CX-2051 Phase 1 study to address certain recent… Full Summary
GLSI Greenwich LifeSciences	$11.85 -0.8%	+6.4%	GLSI-100 Breast cancer recurrences		8/13/2025 - Provided Update Greenwich LifeSciences, Inc. announced the addition of clinical sites in Romania. Full Summary
OCGN Ocugen	$1.01	-1.9%	OCU410ST For Stargardt Disease	EMA	8/13/2025 - review Ocugen, Inc announced that the Committee for Medicinal Products for Human Use (CHMP) of the European… Full Summary
ALGS Aligos Therapeutics	$9.84 +11.2%	+7.9%	ALG-000184 Hepatitis B	Phase 2b	8/13/2025 - Dose Update Aligos Therapeutics, Inc. announced that dosing in the Phase 2 B-SUPREME study of its investigationa… Full Summary
INVA Innoviva	$19.97 +0.1%	+3.6%	XACDURO® XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use is a combination of sulbactam, a beta-lactam antibacterial, and durlobactam, a beta-lactamase inhibitor		8/13/2025 - Provided Update Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. announced that two of the company's… Full Summary
MRK Merck & Co., Inc.	$86.06 +1.7%	+5.3%	KEYNOTE-689 In Patients With Resected, Locally Advanced Head and Neck Squamous Cell Carcinoma	Health Canada Approval	8/13/2025 - Approved Merck announced today that Health Canada has granted approval for KEYTRUDA® (pembrolizumab), Merck'… Full Summary
PRTC PureTech Health	$18.53 +0.9%	+1.6%	VE202 Inflammatory Bowel Disease	Phase 2	8/13/2025 - Endpoint Missed PureTech Health plc announced that its candidate VE202 did not meet the primary endpoint in the Pha… Full Summary
OCUL Ocular Therapeutix	$12.13 +1.4%	+5.0%	AXPAXLI In Diabetic Retinopathy		8/12/2025 - Provided Update Ocular Therapeutix, Inc. announced it has received written agreement regarding a registrational tri… Full Summary
AARD Aardvark Therapeutics	$9.73 +0.6%	-29.2%	ARD-201 For the treatment of metabolic obesity and obesity-related conditions.		8/12/2025 - Positive Data Aardvark Therapeutics, Inc. announced new positive preclinical data demonstrating the potential of … Full Summary
MIRA MIRA Pharmaceuticals	$1.40 -1.4%	-20.0%	Ketamir-2 To treat depression and treatment-resistant depression (TRD).		8/12/2025 - Provided Update MIRA Pharmaceuticals announced the acceptance of a second peer-reviewed manuscript describing its le… Full Summary
INSM Insmed	$132.60 +2.4%	+28.8%	Brensocatib In Patients with Bronchiectasis		8/12/2025 - FDA approved Insmed Incorporated announced that the U.S. Food and Drug Administration (FDA) has approved first-i… Full Summary
CGTX Cognition Therapeutics	$1.99 -1.5%	+156.7%	CT1812 Designed to penetrate the blood-retinal barrier and bind selectively and saturably to the σ-2 receptor complex.	Phase 2	8/12/2025 - Meeting minutes Cognition Therapeutics, announced that it has received final minutes from the U.S. Food and Drug A… Full Summary
NRXP NRx Pharmaceuticals	$2.53 -3.4%	-15.4%	NRX-100 To treat acute depression and suicidality	Fast Track	8/11/2025 - Designation Grant NRx Pharmaceuticals, Inc. announced US Food and Drug Administration (FDA) has granted Fast Track de… Full Summary
AMPH Amphastar Pharmaceuticals	$29.66 +0.1%	+38.9%	Venofer In patients with chronic kidney disease (CKD).		8/11/2025 - FDA approved Amphastar Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration ("FDA") has ap… Full Summary
NVS Novartis	$126.82 -0.3%	+8.4%	ianalumab In adults with active Sjögren's disease.	Phase 3	8/11/2025 - Top-line results Novartis announced positive top-line results from its Phase III trials evaluating ianalumab (VAY736)… Full Summary
IOBT IO Biotech	$1.77 -5.9%	-9.2%	Cylembio For the Treatment of First-line Advanced Melanoma	Phase 3	8/11/2025 - Top-line results IO Biotech announces topline results from the pivotal Phase 3 trial of its investigational, immune-m… Full Summary
QNTM Quantum Biopharma	$18.05 -0.5%	-17.4%	Lucid-MS For people to gain back mobility lost with multiple sclerosis (MS).		8/11/2025 - Provided Update Quantum BioPharma Ltd. announces through its subsidiary, Huge Biopharma Australia Pty Ltd., that i… Full Summary
TLSA Tiziana Life Sciences	$1.93 +6.6%	+19.1%	Foralumab Crohn's disease with decreases in the classic side effects of cytokine release syndrome	IND	8/11/2025 - FDA approved Tiziana Life Sciences, Ltd. is pleased to announce that the U.S. Food & Drug Administration (FDA) h… Full Summary
STOK Stoke Therapeutics	$19.68 +1.9%	+45.0%	zorevunersen For the treatment of Dravet syndrome with a confirmed mutation,	Phase 3	8/11/2025 - Dosing Update Stoke Therapeutics, Inc announced that the first patient has been dosed in the global Phase 3 EMPER… Full Summary
INO Inovio Pharmaceuticals	$1.91 +3.2%	+31.7%	INO-3107 For the Treatment of Recurrent Respiratory Papillomatosis		8/11/2025 - Peer-reviewed data INOVIO nnounced that peer-reviewed data from a retrospective study investigating the long-term clini… Full Summary
IMAB I-Mab	$4.71 +4.2%	+126.4%	Givastomig In patients with advanced cancers	Phase 1b	8/11/2025 - Enrollment Update I-Mab announced that enrollment in the planned Phase 1b dose expansion cohorts evaluating givastomi… Full Summary
MRK Merck & Co., Inc.	$86.06 +1.7%	+5.3%	EV-303 For Certain Patients with Muscle-Invasive Bladder Cancer	Phase 3	8/11/2025 - Top-line results Merck announced positive topline results from the Phase 3 KEYNOTE-905 trial (also known as EV-303) i… Full Summary
NVCT Nuvectis Pharma	$6.34 -3.1%	-21.5%	NXP900 Novel inhibitor of the SRC family of kinases	Phase 1b	8/11/2025 - Provided Update Nuvectis Pharma, Inc. announced the initiation of the Phase 1b program for NXP900. Full Summary
ASMB Assembly Biosciences	$26.65 +1.9%	+42.7%	ABI-5366 For recurrent genital herpes.		8/8/2025 - Positive Results Assembly Biosciences, Inc announced positive interim antiviral activity, clinical outcomes, safety … Full Summary
OBIO Orchestra BioMed	$2.49 +2.5%	-22.2%	BACKBEAT AVIM therapy in pacemaker-indicated patients with uncontrolled hypertension despite the use of antihypertensive medications.		8/8/2025 - FDA approved Orchestra BioMed Holdings, announced the roll out of a protocol update, approved by the U.S. Food … Full Summary
ARVN Arvinas	$7.30 +2.8%	-3.7%	Vepdegestrant For ER positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer.	NDA Target date: June 05, 2026	8/8/2025 - PDUFA Date Arvinas, Inc. announced that The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action d… Full Summary
CAPR Capricor Therapeutics	$7.01 -2.2%	+7.5%	deramiocel For the treatment of Duchenne muscular dystrophy (DMD)	Type A Meeting	8/8/2025 - FDA Meeting Capricor Therapeutics announced that a Type A meeting with the U.S. Food and Drug Administration (… Full Summary
NYXH Nyxoah	$6.35 +0.2%	-18.6%	Genio For the Treatment of Obstructive Sleep Apnea		8/8/2025 - FDA approved Nyxoah SA announced that the U.S. Food and Drug Administration (FDA) has approved the Genio system f… Full Summary
IXHL Incannex Healthcare	$0.46 +13.0%	-45.5%	IHL-42X Obstructive Sleep Apnoea (OSA)	Phase 2	8/8/2025 - Findings Update Incannex Healthcare Inc announced new patient-reported outcome findings from a subset of participant… Full Summary
ARVN Arvinas	$7.30 +2.8%	-3.7%	Vepdegestrant For ER positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer.	NDA	8/8/2025 - FDA Accepted Arvinas, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug A… Full Summary
VTVT vTv Therapeutics	$15.26 +1.8%	-10.4%	Cadisegliatin For Type 1 Diabetes	Phase 3	8/7/2025 - Provided Update vTv Therapeutics Inc. announced the first study participant has been randomized in the Company's CA… Full Summary
FGEN FibroGen	$11.09 +4.4%	+43.8%	roxadustat Anemia of chronic kidney disease (CKD)	Target date: Q4 2025	8/7/2025 - Provided Update FibroGen announced that Company intends to file the Phase 3 protocol in the fourth quarter of 2025 Full Summary
SLS SELLAS Life Sciences Group	$1.76 -4.9%	-4.3%	galinpepimut-S (GPS) Targets the WT1 protein, which is present in an array of tumor types.	Phase 3	8/7/2025 - Analysis SELLAS Life Sciences Group, Inc. announced that the Independent Data Monitoring Committee (IDMC) ha… Full Summary
LLY Eli Lilly and Company	$708.82 +0.5%	-8.7%	orforglipron Orforglipron for the treatment of obesity and overweight	Phase 3	8/7/2025 - Top-line results Eli Lilly and Company announced positive topline results from the Phase 3 ATTAIN-1 trial, evaluatin… Full Summary
FGEN FibroGen	$11.09 +4.4%	+43.8%	roxadustat Anemia of chronic kidney disease (CKD)	FDA Type C Meeting	8/7/2025 - Positive Feedback FibroGen announced positive feedback from its Type C meeting with the FDA, supporting the advanceme… Full Summary
JAZZ Jazz Pharmaceuticals	$120.53 +1.2%	+3.6%	dordaviprone treatment for recurrent H3 K27M-mutant diffuse glioma		8/6/2025 - FDA GRANT Jazz Pharmaceuticals plc announced that the U.S. Food and Drug Administration (FDA) has granted acc… Full Summary

Written by Jessica Mitacek | Reviewed by Don Miller

July 18, 2025

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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.

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FDA Event Stage Terminology & Abbreviation Guide

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

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Frequently Asked Questions

What types of FDA events are listed here?

What is a PDUFA date and why does it matter?

What are Phase 1, 2, and 3 clinical trials?

What is the difference between Submission, Review, and Approval?

What’s the difference between FDA Grant and Target Date?

What are special designations like Breakthrough Therapy or Orphan Drug?

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