FDA Calendar: PDUFA Dates, FDA Decisions & Clinical Trial Milestones
Stay ahead of biotech and pharmaceutical market-moving events with the CatalystPICR FDA Calendar. Track upcoming PDUFA dates, FDA approvals, Complete Response Letters (CRLs) and rejections, Advisory Committee meetings, and important clinical trial milestones that can significantly impact stock prices.
Tips: Click on the row to see the CATALYST!
FDA Announcements
date
Symbol
Company
time
event_type
Drug
Drug Details
Status
Catalyst
target_date_from
target_date_to
Catalyst Summary
Source
PDUFA Dates
date
time
Symbol
Company
event_type
Drug
Drug Details
Status
Catalyst
Target
target_date_from
target_date_to
Catalyst Summary
Source
02/18/2026
07:00 AM
MRNA
Moderna
PDUFA
mRNA-1010
mRNA-1010, an investigational seasonal influenza vaccine candidate
Biologics License Application (BLA)
PDUFA
05-Aug-2026
08/05/2026
08/05/2026
After the submission of the revised application, the FDA has approved Moderna's (MRNA) biologics license application (BLA) for evaluation and has set a Prescription Drug User Fee Act (PDUFA) target date of August 5, 2026. Subject to review and FDA authorization, mRNA-1010 is expected to be accessible for adults aged 50 and above in the United States.
10/28/2025
08:30 AM
LNTH
Lantheus Holdings
PDUFA
MK-6240
MK-6240, the company’s investigational F18-labeled tau-targeted Positron Emission Tomography (PET) imaging agent for the detection of tau neurofibrillary tangle (NFT) pathology in patients with cognitive impairment being evaluated for Alzheimer’s disease.
New Drug Application (NDA)
PDUFA
13-Aug-2026
08/13/2026
08/13/2026
Lantheus Holdings (LNTH) has announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for MK-6240. This investigational F18-labeled tau-targeted Positron Emission Tomography (PET) imaging agent is designed for the detection of tau neurofibrillary tangle (NFT) pathology in patients with cognitive impairment who are being assessed for Alzheimer’s disease. The FDA has established a target action date of August 13, 2026, under the Prescription Drug User Fee Act (PDUFA).
02/17/2026
06:59 AM
BMY
Bristol Myers Squibb
PDUFA
Iberdomide + standard treatment (daratumumab + dexamethasone - IberDd)
Iberdomide combined with standard treatment (daratumumab + dexamethasone - IberDd) in patients with relapsed or refractory multiple myeloma (RRMM).
New Drug Application (NDA) Priority Review
PDUFA
17-Aug-2026
08/17/2026
08/17/2026
Bristol Myers Squibb (BMY) has revealed that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for iberdomide in conjunction with standard treatment (daratumumab + dexamethasone - IberDd) for patients suffering from relapsed or refractory multiple myeloma (RRMM). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of August 17, 2026, for this indication.
KEYTRUDA® (pembrolizumab) in combination with Padcev® (enfortumab vedotin-ejfv), for the treatment of patients with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-based chemotherapy.
Merck (MRK) has announced that the U.S. Food and Drug Administration (FDA) has granted priority review for the supplemental Biologics License Application (sBLA) concerning KEYTRUDA® (pembrolizumab) in conjunction with Padcev® (enfortumab vedotin-ejfv). This combination is intended for the treatment of patients diagnosed with muscle-invasive bladder cancer (MIBC) who qualify for cisplatin-based chemotherapy. The FDA has established a target action date of August 17, 2026, under the Prescription Drug User Fee Act (PDUFA).
04/20/2026
06:48 AM
MRK
Merck
PDUFA
KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) + Padcev® (enfortumab vedotin-ejfv)
KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Merck’s anti-PD-1 therapy, in combination with Padcev® (enfortumab vedotin-ejfv), for the treatment of patients with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-based chemotherapy.
Merck (MRK) has announced that the U.S. Food and Drug Administration (FDA) has granted priority review for the supplemental Biologics License Application (sBLA) concerning KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), which is Merck’s anti-PD-1 therapy. This application is in combination with Padcev® (enfortumab vedotin-ejfv) for the treatment of patients diagnosed with muscle-invasive bladder cancer (MIBC) who qualify for cisplatin-based chemotherapy. The FDA has established a Prescription Drug User Fee Act (PDUFA) target action date of August 17, 2026.
03/10/2026
09:25 AM
CAPR
Capricor Therapeutics
PDUFA
Deramiocel
Deramiocel, an investigational cell therapy, for the treatment of Duchenne muscular dystrophy (DMD) cardiomyopathy.
Biologics License Application (BLA)
PDUFA
22-Aug-2026
08/22/2026
08/22/2026
Capricor Therapeutics (CAPR) has revealed that the U.S. Food and Drug Administration (FDA) has revoked the earlier Complete Response Letter and has recommenced the evaluation of its Biologics License Application (BLA) aimed at obtaining full approval for Deramiocel, an experimental cell therapy intended for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy (DMD). This submission has been designated as a Class 2 resubmission, with a target action date under the Prescription Drug User Fee Act (PDUFA) set for August 22, 2026.
Ultragenyx Pharmaceutical (RARE) announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for review, which is intended to secure approval for DTX401 AAV gene therapy (pariglasgene brecaparvovec) for the management of Glycogen Storage Disease Type Ia (GSDIa). The FDA has granted Priority Review status to the BLA and established a Prescription Drug User Fee Act (PDUFA) action date of August 23, 2026.
A once‑weekly lecanemab‑irmb subcutaneous injection (U.S. brand name: LEQEMBI® IQLIK™) as a starting dose for the treatment of early Alzheimer's disease.
supplemental Biologics License Application (sBLA)
PDUFA
24-Aug-2026
08/24/2026
08/24/2026
Eisai Co., Ltd. and Biogen Inc. (BIIB) have announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the supplemental Biologics License Application (sBLA) by three months. This application pertains to a once-weekly lecanemab-irmb subcutaneous injection, marketed in the U.S. as LEQEMBI® IQLIK™, intended as a starting dose for treating early Alzheimer's disease. The revised action date under the Prescription Drug User Fee Act (PDUFA) is now set for August 24, 2026.
04/27/2026
07:45 AM
JAZZ
Jazz Pharmaceuticals plc
PDUFA
Ziihera® (zanidatamab-hrii)
Ziihera® (zanidatamab-hrii) containing combinations for the first-line treatment of adult patients with HER2-positive (HER2+) unresectable locally advanced or metastatic gastric, gastroesophageal junction (GEJ), or gastroesophageal adenocarcinoma (GEA).
Jazz Pharmaceuticals plc (JAZZ) announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Ziihera® (zanidatamab-hrii) for Priority Review. This application includes combinations intended for the first-line treatment of adult patients diagnosed with HER2-positive (HER2+) unresectable locally advanced or metastatic gastric, gastroesophageal junction (GEJ), or gastroesophageal adenocarcinoma (GEA). The FDA has established a target action date of August 25, 2026, under the Prescription Drug User Fee Act (PDUFA).
04/29/2026
08:30 AM
GILD
Gilead Sciences
PDUFA
Bictegravir 75 mg/ Lenacapavir 50 mg (BIC/LEN)
Bictegravir 75 mg/ Lenacapavir 50 mg (BIC/LEN) an investigational, once-daily single-tablet combination regimen for the treatment of HIV in adults who are virologically suppressed.
New Drug Application (NDA)
PDUFA
27-Aug-2026
08/27/2026
08/27/2026
Gilead Sciences, Inc. (Nasdaq: GILD) has announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for bictegravir 75 mg/lenacapavir 50 mg (BIC/LEN). This investigational regimen is a once-daily single-tablet combination designed for the treatment of HIV in adults who are virologically suppressed. The FDA has granted priority review for this application and has set a Prescription Drug User Fee Act (PDUFA) action date of August 27, 2026.
Clinical Trials
date
Symbol
Company
time
event_type
Drug
Drug Details
Status
Catalyst
target_date_from
target_date_to
Catalyst Summary
Source
Sign-Up to see the full list of FDA Catalysts
Note: Our FDA Calendar provides investors with a centralized view of key regulatory events, helping you monitor expected decision dates, drug development progress, trial outcomes, and other catalysts across the biotechnology sector. Whether you’re following an upcoming FDA approval, a Phase 2 or Phase 3 clinical trial readout, or regulatory updates for a specific company, this calendar is designed to keep you informed of the events that matter most.
Bookmark this page to stay updated on upcoming biotech catalysts and make more informed investment decisions.
