The U.S. Food and Drug Administration (FDA) provides the Prescription Drug User Fee Act date which marks the deadline by which the FDA must complete its review of drug applications. Occasionally, an advisory committee meeting is convened to assess drugs or devices under consideration. Presented below is a compiled list of drugs and devices, along with the anticipated decision date currently accurate as of June 29, 2026.

Upcoming FDA Decisions for the Third Quarter of 2026

Atacicept (BLA), July 7

  • Vera Therapeutics
  • For the treatment of adults with immunoglobulin A nephropathy (IgAN)

Enhertu (sBLA), July 7

  • AstraZeneca
  • As post-neoadjuvant treatment for patients with HER2-positive early breast cancer.

Enhertu (sBLA), July 7

  • Daiichi Sankyo 
  • As post-neoadjuvant treatment for patients with HER2-positive early breast cancer.

Relacorilant (NDA), July 11

  • Corcept Therapeutics
  • As a treatment for patients with platinum-resistant ovarian cancer.

Gedatolisib (NDA), July 17

  • Celcuity
  • In hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER-2), PIK3CA wild-type advanced breast cancer.

Rivoceranib (Resubmitted NDA), July 23

  • HLB
  • In combination with camrelizumab as a first-line systemic treatment for unresectable hepatocellular carcinoma.

Sarclisa SC (BLA), July 23

  • Sanofi
  • In combination with approved standard-of-care regimens for the treatment of patients with multiple myeloma across all currently approved US indications of sarclisa intravenous (IV) formulation.

Centanafadine (NDA), July 24

  • Otsuka Holdings
  • For the treatment of attention-deficit hyperactivity disorder (ADHD) in children, adolescents, and adults.

Furoscix ReadyFlow Autoinjector (sNDA), July 26

  • MannKind
  • For the treatment of edema in adults with chronic heart failure or chronic kidney disease.

Ketafree (ANDA), July 29

  • NRx Pharmaceuticals
  • A preservative-free intravenous ketamine formulation.

Deramiocel (BLA), July 29

  • Capricor Therapeutics
  • For the treatment of Duchenne muscular dystrophy.

ONS-5010/LYTENAVA, July 29

  • Outlook Therapeutics
  • For the treatment of neovascular age-related macular degeneration.

Low Dose Estrogen Weekly Patch (NDA), July 30

  • Viatris
  • For contraception.

Garetosmab (BLA), August*

  • Regeneron Pharmaceuticals
  • For the treatment of adults with fibrodysplasia ossificans progressiva (FOP).

RP1 (vusolimogene oderparapvec)(Resubmitted BLA), August 2

  • Replimune Group
  • In combination with nivolumab for the treatment of advanced melanoma.

mRNA-1010 (BLA), August 5

  • Moderna
  • A seasonal influenza vaccine candidate.

MK-6240, a PET Imaging Agent (NDA), August 13

  • Lantheus Holdings
  • For the detection of tau neurofibrillary tangle (NFT) pathology in patients with cognitive impairment being evaluated for Alzheimer’s disease.

Padcev (sBLA), August 17

  • Pfizer
  • For patients with muscle-invasive bladder cancer regardless of cisplatin eligibility.

Padcev (sBLA), August 17

  • Astellas Pharma
  • For patients with muscle-invasive bladder cancer regardless of cisplatin eligibility.

Iberdomide (NDA), August 17

  • Bristol Myers Squibb
  • For patients with relapsed or refractory multiple myeloma.

Keytruda (sBLA), August 17

  • Merck & Co
  • In combination with Padcev for the treatment of patients with muscle-invasive bladder cancer.

Deramiocel (resubmitted BLA), August 22

  • Capricor Therapeutics
  • To treat Duchenne muscular dystrophy cardiomyopathy. 

DTX401 (BLA), August 23

  • Ultragenyx Pharmaceutical
  • For the treatment of glycogen storage disease type Ia (GSDIa).

Leqembi Iqlik (sBLA), August 24

  • Eisai Co
  • As a weekly starting dose, for the treatment of early Alzheimer’s disease.

Leqembi Iqlik (sBLA), August 24

  • Biogen
  • As a weekly starting dose, for the treatment of early Alzheimer’s disease.

Ziihera (sBLA), August 25

  • Zymeworks
  • Ziihera combinations in first-line HER2+ locally advanced or metastatic gastroesophageal adenocarcinoma.

Ziihera (sBLA), August 25

  • Jazz Pharmaceuticals
  • Ziihera combinations in first-line HER2+ locally advanced or metastatic gastroesophageal adenocarcinoma.

Ziihera (sBLA), August 25

  • Royalty Pharma
  • Ziihera combinations in first-line HER2+ locally advanced or metastatic gastroesophageal adenocarcinoma.

Bictegravir Plus Lenacapavir, August 27

  • Gilead Sciences
  • For the treatment of HIV in adults.

Ropeginterferon alfa-2b-njft (sBLA), August 30

  • PharmaEssentia Corporation
  • For the treatment of adult patients with essential thrombocythemia.

Besremi (sBLA), August 30

  • PharmaEssentia Corporation
  • For the treatment of patients with essential thrombocythemia (ET).

TLX101-Px1 (resubmitted NDA), September 11

  • Telix Pharmaceuticals
  • An agent for the imaging of glioma.

Zidesamtinib (NDA), September 18

  • Nuvalent
  • For the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer who received at least 1 prior ROS1 tyrosine kinase inhibitor.

Zidesamtinib (NDA), September 18

  • Royalty Pharma
  • For the treatment of locally advanced or metastatic ROS1-positive non-small cell lung cancer in adults. 

UX111 AAV (Resubmitted BLA), September 19

  • Ultragenyx Pharmaceutical
  • For treatment of Sanfilippo syndrome type A (MPS IIIA).

Winrevair (sBLA), September 21

  • Merck & Co
  • Label update in pulmonary arterial hypertension to include Phase 2 HYPERION trial results.

Zilganerson (NDA), September 22

  • Ionis Pharmaceuticals
  • For the treatment of Alexander disease.

Zlurgisertib (NDA), September 26

  • Incyte Corporation
  • For the treatment of fibrodyplasia ossificans progressiva (FOP).

Zlurgisertib (NDA), September 26

  • Mirum Pharmaceuticals
  • For the treatment of fibrodyplasia ossificans progressiva (FOP).

Relutrigine (NDA), September 27

  • Praxis Precision Medicines
  • For the treatment of SCN2A and SCN8A developmental and epileptic encephalopathies.

Ameluz PDT (sNDA), September 28

  • Biofrontera
  • For the treatment of superficial basal cell carcinoma.

Ameluz (sNDA), September 28

  • Biofrontera
  • Expanded indication of Ameluz PDT in superficial basal cell carcinoma. 

Camzyos (sNDA), September 30

  • Bristol Myers Squibb
  • Treatment for adolescents (12 to under 18 years old) with symptomatic obstructive hypertrophic cardiomyopathy.

Apitegromab (resubmitted BLA), September 30

  • Scholar Rock Holding
  • For the treatment of children and adults with spinal muscular atrophy.

*Please note that drugs marked with an asterix only specified the anticipated month.

Sign up for alerts and stay informed on the latest published guidelines and articles.