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Pfizer (PFE) FDA Events

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FDA Events for Pfizer (PFE)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Pfizer (PFE). Over the past two years, Pfizer has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as ABRYSVO, ADCETRIS, BRAFTOVI, BRAFTOVI®, CABOTEGRAVIR, CIFFREO, and COMIRNATY®. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Pfizer's Drugs in FDA Review

ABRYSVO - FDA Regulatory Timeline and Events

ABRYSVO is a drug developed by Pfizer for the following indication: Vaccine indicated for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in people 60 years of age and older. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

ADCETRIS - FDA Regulatory Timeline and Events

ADCETRIS is a drug developed by Pfizer for the following indication: Prescription medicine directed against the CD30 protein. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

BRAFTOVI - FDA Regulatory Timeline and Events

BRAFTOVI is a drug developed by Pfizer for the following indication: In Patients with BRAF V600E-Mutant Metastatic Colorectal Cancer. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

BRAFTOVI® + MEKTOVI - FDA Regulatory Timeline and Events

BRAFTOVI® + MEKTOVI is a drug developed by Pfizer for the following indication: For the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

CABOTEGRAVIR - FDA Regulatory Timeline and Events

CABOTEGRAVIR is a drug developed by Pfizer for the following indication: FOR PREVENTION OF HIV. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

CIFFREO - FDA Regulatory Timeline and Events

CIFFREO is a drug developed by Pfizer for the following indication: In ambulatory patients with Duchenne muscular dystrophy (DMD). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

COMIRNATY® JN.1 - FDA Regulatory Timeline and Events

COMIRNATY® JN.1 is a drug developed by Pfizer for the following indication: monovalent COVID-19 vaccine. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

danuglipron - FDA Regulatory Timeline and Events

danuglipron is a drug developed by Pfizer for the following indication: Glucagon-like peptide-1 antagonists. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Dovato - FDA Regulatory Timeline and Events

Dovato is a drug developed by Pfizer for the following indication: For adolescents living with HIV. This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Elranatamab - FDA Regulatory Timeline and Events

Elranatamab is a drug developed by Pfizer for the following indication: B-cell maturation antigen (BCMA)-CD3-targeted bispecific antibody (BsAb). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

EMBLAVEO - FDA Regulatory Timeline and Events

EMBLAVEO is a drug developed by Pfizer for the following indication: In the treatment of adult patients with complicated intra-abdominal infections (cIAI). This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

EV-302 - FDA Regulatory Timeline and Events

EV-302 is a drug developed by Pfizer for the following indication: For the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Fidanacogene Elaparvovec - FDA Regulatory Timeline and Events

Fidanacogene Elaparvovec is a drug developed by Pfizer for the following indication: Hemophilia B gene therapy. This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

giroctocogene fitelparvovec - FDA Regulatory Timeline and Events

giroctocogene fitelparvovec is a drug developed by Pfizer for the following indication: For the treatment of adults with moderately severe to severe hemophilia A. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

HYMPAVZI - FDA Regulatory Timeline and Events

HYMPAVZI is a drug developed by Pfizer for the following indication: For the Treatment of Adults and Adolescents with Hemophilia A or B Without Inhibitors. This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

LORBRENA (lorlatinib) - FDA Regulatory Timeline and Events

LORBRENA (lorlatinib) is a drug developed by Pfizer for the following indication: anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

LORVIQUA (lorlatinib) - FDA Regulatory Timeline and Events

LORVIQUA (lorlatinib) is a drug developed by Pfizer for the following indication: Anaplastic lymphoma kinase (ALK)- positive advanced non-small cell lung cancer (NSCLC). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

mRNA vaccine - FDA Regulatory Timeline and Events

mRNA vaccine is a drug developed by Pfizer for the following indication: Against influenza and COVID-19 in healthy individuals 18-64 years of age. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Omicron KP.2 - FDA Regulatory Timeline and Events

Omicron KP.2 is a drug developed by Pfizer for the following indication: For Omicron KP.2-adapted COVID-19 Vaccine. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Oxbryta (voxelotor) - FDA Regulatory Timeline and Events

Oxbryta (voxelotor) is a drug developed by Pfizer for the following indication: Sickle Cell Disease in Children Ages 4 to 11. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

palbociclib - FDA Regulatory Timeline and Events

palbociclib is a drug developed by Pfizer for the following indication: In Patients With HR+, HER2+ Metastatic Breast Cancer. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

ponsegromab - FDA Regulatory Timeline and Events

ponsegromab is a drug developed by Pfizer for the following indication: In Patients with Cancer Cachexia. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

sasanlimab - FDA Regulatory Timeline and Events

sasanlimab is a drug developed by Pfizer for the following indication: In patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

TALZENNA - FDA Regulatory Timeline and Events

TALZENNA is a drug developed by Pfizer for the following indication: Oral inhibitor of poly ADP-ribose polymerase. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

TIVDAK - FDA Regulatory Timeline and Events

TIVDAK is a drug developed by Pfizer for the following indication: For Patients with Recurrent or Metastatic Cervical Cancer. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

VLA15-221 - FDA Regulatory Timeline and Events

VLA15-221 is a drug developed by Pfizer for the following indication: For Lyme Disease Vaccine Candidate. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

XTANDI (Enzalutamide) - FDA Regulatory Timeline and Events

XTANDI (Enzalutamide) is a drug developed by Pfizer for the following indication: Metastatic Hormone-Sensitive Prostate Cancer. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Pfizer FDA Events - Frequently Asked Questions

Yes, Pfizer (PFE) has received FDA approval for multiple therapies, including EMBLAVEO, HYMPAVZI, Fidanacogene Elaparvovec and Dovato. This page tracks recent and historical FDA regulatory events related to Pfizer's drug portfolio.

In the past two years, Pfizer (PFE) has reported FDA regulatory activity for the following drugs: ABRYSVO, HYMPAVZI, BRAFTOVI, Dovato, sasanlimab, TIVDAK, ADCETRIS, giroctocogene fitelparvovec, danuglipron, Elranatamab, XTANDI (Enzalutamide), CABOTEGRAVIR, EV-302, EMBLAVEO, palbociclib, TALZENNA, Oxbryta (voxelotor), BRAFTOVI® + MEKTOVI, ponsegromab, VLA15-221, Omicron KP.2, mRNA vaccine, COMIRNATY® JN.1, CIFFREO, LORVIQUA (lorlatinib), LORBRENA (lorlatinib) and Fidanacogene Elaparvovec.

The most recent FDA-related event for Pfizer occurred on July 10, 2025, involving XTANDI (Enzalutamide). The update was categorized as "Top-line results," with the company reporting: "Pfizer Inc. and Astellas Pharma Inc announced positive topline results from the overall survival (OS) analysis from the Phase 3 EMBARK study evaluating XTANDI® (enzalutamide), in combination with leuprolide and as a monotherapy, in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC; also known as nonmetastatic castration-sensitive prostate cancer or nmCSPC) with biochemical recurrence (BCR) at high risk for metastasis."

Current therapies from Pfizer in review with the FDA target conditions such as:

  • Vaccine indicated for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in people 60 years of age and older. - ABRYSVO
  • For the Treatment of Adults and Adolescents with Hemophilia A or B Without Inhibitors - HYMPAVZI
  • In Patients with BRAF V600E-Mutant Metastatic Colorectal Cancer - BRAFTOVI
  • For adolescents living with HIV - Dovato
  • In patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC). - sasanlimab
  • For Patients with Recurrent or Metastatic Cervical Cancer - TIVDAK
  • Prescription medicine directed against the CD30 protein - ADCETRIS
  • For the treatment of adults with moderately severe to severe hemophilia A. - giroctocogene fitelparvovec
  • Glucagon-like peptide-1 antagonists. - danuglipron
  • B-cell maturation antigen (BCMA)-CD3-targeted bispecific antibody (BsAb). - Elranatamab
  • Metastatic Hormone-Sensitive Prostate Cancer - XTANDI (Enzalutamide)
  • FOR PREVENTION OF HIV - CABOTEGRAVIR
  • For the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) - EV-302
  • In the treatment of adult patients with complicated intra-abdominal infections (cIAI) - EMBLAVEO
  • In Patients With HR+, HER2+ Metastatic Breast Cancer - palbociclib
  • Oral inhibitor of poly ADP-ribose polymerase - TALZENNA
  • Sickle Cell Disease in Children Ages 4 to 11 - Oxbryta (voxelotor)
  • For the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation - BRAFTOVI® + MEKTOVI
  • In Patients with Cancer Cachexia - ponsegromab
  • For Lyme Disease Vaccine Candidate - VLA15-221
  • For Omicron KP.2-adapted COVID-19 Vaccine - Omicron KP.2
  • Against influenza and COVID-19 in healthy individuals 18-64 years of age. - mRNA vaccine
  • monovalent COVID-19 vaccine - COMIRNATY® JN.1
  • In ambulatory patients with Duchenne muscular dystrophy (DMD) - CIFFREO
  • Anaplastic lymphoma kinase (ALK)- positive advanced non-small cell lung cancer (NSCLC) - LORVIQUA (lorlatinib)
  • anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) - LORBRENA (lorlatinib)
  • Hemophilia B gene therapy - Fidanacogene Elaparvovec

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

This page (NYSE:PFE) was last updated on 7/10/2025 by MarketBeat.com Staff
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