Upcoming August 2026 Prescription Drug User Fee Act dates include regulatory decisions for therapies and products targeting seasonal influenza, tau positron emission tomography imaging in patients being evaluated for Alzheimer disease, relapsed or refractory multiple myeloma, Duchenne muscular dystrophy, autoimmune pulmonary alveolar proteinosis, glycogen storage disease type Ia, HER2-positive gastric, gastroesophageal junction, or gastroesophageal adenocarcinoma, HIV in adults with virologic suppression, essential thrombocythemia, and fibrodysplasia ossificans progressiva.
Infectious Disease
mRNA-1010
Moderna announced an August 5, 2026, Prescription Drug User Fee Act (PDUFA) target action date for its biologics license application for mRNA-1010, an investigational seasonal influenza vaccine. The application includes data from Moderna’s phase 3 clinical program. According to Moderna, the US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee voted unanimously that the vaccine’s benefits outweighed the risks for preventing influenza in adults aged 50 to 64 years and in adults aged 65 years or older.
Source: Moderna Inc.
Bictegravir/lenacapavir
Gilead Sciences announced that the FDA accepted for Priority Review its new drug application for bictegravir 75 mg/lenacapavir 50 mg, an investigational once-daily single-tablet regimen for adults with HIV who are virologically suppressed. The agency assigned an August 27, 2026, PDUFA target action date. According to Gilead Sciences, the application is supported by phase 3 data from the ARTISTRY-1 and ARTISTRY-2 trials.
Source: Gilead Sciences
Neurology
MK-6240
Lantheus announced that the FDA assigned an August 13, 2026, PDUFA target action date for its new drug application for MK-6240, an investigational fluorine-18-labeled positron emission tomography imaging agent intended to identify tau neurofibrillary tangle pathology in patients with cognitive impairment being evaluated for Alzheimer disease. The application is supported by two pivotal phase 3 clinical trials. According to Lantheus, both studies met their predefined diagnostic sensitivity and specificity endpoints for detecting tau neurofibrillary tangles.
Source: Lantheus
Deramiocel
Capricor Therapeutics announced an August 22, 2026, PDUFA target action date for its biologics license application for deramiocel, an investigational cell therapy for Duchenne muscular dystrophy. The application is supported by findings from the phase 2 HOPE-2 trial, long-term follow-up from the HOPE-2 open-label extension, and the phase 3 HOPE-3 trial. According to Capricor Therapeutics, the FDA's Cellular, Tissue, and Gene Therapies Advisory Committee met July 29, 2026, to review the application.
Source: Capricor Therapeutics
Oncology
Iberdomide
Bristol Myers Squibb announced an August 17, 2026, PDUFA target action date for its new drug application for iberdomide in combination with daratumumab and dexamethasone for patients with relapsed or refractory multiple myeloma. The submission is based on a planned analysis from the ongoing phase 3 EXCALIBER-RRMM trial. According to Bristol Myers Squibb, the FDA also granted Breakthrough Therapy designation for the investigational regimen.
Source: Bristol Myers Squibb
Ziihera (zanidatamab-hrii)
Jazz Pharmaceuticals announced that the FDA accepted the supplemental biologics license application for Ziihera (zanidatamab-hrii) in combination with standard-of-care chemotherapy, with or without tislelizumab, for the first-line treatment of adults with HER2-positive unresectable locally advanced or metastatic gastric, gastroesophageal junction, or gastroesophageal adenocarcinoma and granted the application Priority Review. The agency assigned an August 25, 2026, PDUFA target action date. According to Jazz Pharmaceuticals, the application is supported by findings from the phase 3 HERIZON-GEA-01 trial.
Source: Jazz Pharmaceuticals
Pulmonary
MOLBREEVI (molgramostim inhalation solution)
Savara announced that the FDA continues to review its biologics license application for MOLBREEVI (molgramostim inhalation solution) for autoimmune pulmonary alveolar proteinosis, with an August 22, 2026, PDUFA target action date. The company said the FDA indicated in its Day 74 letter that an advisory committee meeting is not planned as part of the review.
Source: Savara
Pediatrics
DTX401 (pariglasgene brecaparvovec)
Ultragenyx announced that the FDA accepted its biologics license application for DTX401 AAV gene therapy (pariglasgene brecaparvovec) for the treatment of glycogen storage disease type Ia and granted Priority Review. The agency assigned an August 23, 2026, PDUFA target action date. According to Ultragenyx, the application is supported by clinical data from 52 treated patients with follow-up of up to 6 years.
Source: Ultragenyx
Hematology
BESREMi (ropeginterferon alfa-2b-njft)
PharmaEssentia announced that its supplemental biologics license application seeking to expand the indication for BESREMi (ropeginterferon alfa-2b-njft) to include essential thrombocythemia is under FDA review, with an August 30, 2026, PDUFA goal date. The company has reported findings from the phase 3 SURPASS-ET trial evaluating ropeginterferon alfa-2b in patients with essential thrombocythemia.
Source: PharmaEssentia
Orthopedic Medicine
Garetosmab
Regeneron Pharmaceuticals announced that the FDA accepted for Priority Review its biologics license application for garetosmab for the treatment of adults with fibrodysplasia ossificans progressiva. The agency assigned a target action date in August 2026. According to Regeneron Pharmaceuticals, the application is supported by efficacy and safety data from the phase 3 OPTIMA trial.
Source: Regeneron Pharmaceuticals
LOOKING AHEAD:
Neurology
Oveporexton (TAK-861)
Takeda announced that the FDA accepted its new drug application for oveporexton (TAK-861), an investigational orexin receptor 2-selective agonist for the treatment of narcolepsy type 1, and granted the application Priority Review. The agency assigned a PDUFA goal date in the third quarter of 2026.
Source: Takeda
Rheumatology
Brepocitinib
Priovant Therapeutics announced that the FDA accepted its new drug application for brepocitinib for the treatment of dermatomyositis and granted Priority Review. The agency assigned a PDUFA target action date in the third quarter of 2026. According to Priovant Therapeutics, the application is supported by results from the phase 3 VALOR trial.
Source: Priovant Therapeutics