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 anticipated decision dates currently accurate as of March 18, 2026.

April 2026
  • Nusinersen (sNDA), April 3
    • Biogen
    • FDA decision on high-dose regimen of nusinersen for people living with spinal muscular atrophy (SMA).
  • Tividenofusp alfa (BLA), April 5
    • Royalty Pharma
    • FDA decision on Tividenofusp alfa for the treatment of Hunter syndrome.
  • Tividenofusp alfa (BLA), April 5
    • Denali Therapeutics
    • FDA decision on Tividenofusp alfa for the treatment of Hunter syndrome.
  • PADCEV (sBLA), April 7
    • Pfizer
    • FDA decision on PADCEV plus KEYTRUDA for patients with muscle-invasive bladder cancer who are ineligible for cisplatin-containing chemotherapy.
  • PADCEV (sBLA), April 7
    • Merck & Co
    • FDA decision on PADCEV plus KEYTRUDA for patients with muscle-invasive bladder cancer who are ineligible for cisplatin-containing chemotherapy.
  • PADCEV (sBLA), April 7
    • AstraZeneca
    • FDA decision on PADCEV plus KEYTRUDA for patients with muscle-invasive bladder cancer who are ineligible for cisplatin-containing chemotherapy.
  • KEYTRUDA (sBLA), April 7
    • Merck & Co
    • FDA decision on KEYTRUDA plus Padcev for the treatment of patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemotherapy.
  • KEYTRUDA QLEX (sBLA), April 7
    • Merck & Co
    • FDA decision on KEYTRUDA QLEX plus Padcev for the treatment of patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemotherapy.
  • Opdivo (sBLA), April 8
    • Bristol Myers Squibb
    • FDA decision on Opdivo plus Chemotherapy combination for previously untreated Stage III or IV Classical Hodgkin Lymphoma.
  • RP1 (Resubmitted BLA), April 10
    • Replimune Group, Inc.
    • FDA decision on RP1 in combination with Bristol Myers Squibb's Opdivo for the treatment of advanced melanoma in patients who progress on an anti-PD-1 containing regimen.
  • FILSPARI (sNDA), April 13
    • Travere Therapeutics
    • FDA decision on FILSPARI (sparsentan) for the treatment of focal segmental glomerulosclerosis (FSGS).
  • FILSPARI (sNDA), April 13
    • Ligand Pharmaceuticals
    • FDA decision on FILSPARI (sparsentan) for the treatment of focal segmental glomerulosclerosis (FSGS).
  • Subcutaneous Sarclisa (sBLA), April 23
    • Sanofi SA
    • FDA decision on subcutaneous Sarclisa in multiple myeloma.
  • GTx-104 (NDA), April 23
    • Grace Therapeutics
    • FDA decision on GTx-104 for the treatment of aneurysmal Subarachnoid Hemorrhage (aSAH).
  • Dupixent (sBLA), April 27
    • Sanofi, SA
    • FDA decision on Dupixent for the treatment of chronic spontaneous urticaria (CSU) in children.
  • Doravirine/Islatravir (NDA), April 28
    • Merck & Co
    • FDA decision on Doravirine/Islatravir, an oral, two-drug regimen for adults with HIV-1 infection that is virologically suppressed on antiretroviral therapy.
  • Tzield (sBLA), April 29
    • Sanofi SA
    • FDA decision on Tzield to expand to as young as one year old and above to delay the onset of stage 3 type 1 diabetes in patients diagnosed with stage 2 T1D.
  • AXS-05, April 30
    • Axsome Therapeutics
    • FDA decision on AXS-05 for the treatment of Alzheimers disease agitation.
May 2026
  • VYVGART (sBLA), May 10
    • Arenx
    • FDA decision on VYVGART with generalized myasthenia gravis who test negative for AChR antibodies (seronegative).
  • VYVGART (sBLA), May 10
    • Zai Lab
    • ​​FDA decision on VYVGART with generalized myasthenia gravis who test negative for AChR antibodies (seronegative).
  • ENHERTU (sBLA), May 18
    • Daiichi Sankyo Company
    • FDA decision on ENHERTU followed by paclitaxel, trastuzumab and pertuzumab for the neoadjuvant treatment of adult patients with HER2 positive breast cancer.
  • ENHERTU, May 18
    • AstraZeneca
    • FDA decision on ENHERTU followed by paclitaxel, trastuzumab and pertuzumab for the neoadjuvant treatment of adult patients with HER2 positive breast cancer.
  • LEQEMBI IQLIK (sBLA), May 24
    • Eisai
    • FDA decision on LEQEMBI IQLIK, as a weekly starting dose, for the treatment of early Alzheimer’s Disease.
  • LEQEMBI IQLIK (sBLA), May 24
    • Biogen
    • FDA decision on LEQEMBI IQLIK, as a weekly starting dose, for the treatment of early Alzheimer’s Disease. 
  • LEQEMBI IQLIK subcutaneous autoinjector (sBLA), May 24
    • BioArctic
    • FDA decision on LEQEMBI IQLIK Subcutaneous Autoinjector for the treatment of Alzheimer’s disease in patients with Mild Cognitive Impairment or mild dementia stage of disease.
  • Affrezza (sBLA), May 29
    • MannKind
    • FDA decision on Afrezza Inhalation Powder in children and adolescents living with type 1 or type 2 diabetes.
  • CTx-1301 (NDA), May 31
    • Cingulate
    • FDA decision on CTx-1301 for the treatment of Attention-Deficit/Hyperactivity Disorder in children and adults.
June 2026
  • DATROWAY (sBLA), June 2
    • Daiichi Sankyo
    • FDA decision on DATROWAY for the treatment of adult patients with unresectable or metastatic triple negative breast cancer who are not candidates for immunotherapy.
  • DATROWAY (sBLA), June 2
    • AstraZeneca
    • FDA decision on DATROWAY for the treatment of adult patients with unresectable or metastatic triple negative breast cancer who are not candidates for immunotherapy.
  • Vepdegestrant (NDA), June 5
    • Arvinas
    • FDA decision on Vepdegestrant for the treatment of ESR1m, ER+/HER2- advanced breast cancer.
  • Vepdegestrant (NDA), June 5
    • Pfizer
    • FDA decision on Vepdegestrant for the treatment of ESR1m, ER+/HER2- advanced breast cancer.
  • Oclaiz, June 10
    • Camurus
    • FDA decision on Oclaiz for the treatment of patients with acromegaly.
  • Tebipenem HBr (NDA), June 18
    • Spero Therapeutics
    • FDA decision on Tebipenem HBr as oral treatment for complicated urinary tract infections (cUTIs), including pyelonephritis.
  • KEYTRUDA plus WELIREG (sNDA), June 19
    • Merck & Co
    • FDA decision on KEYTRUDA in combination with WELIREG given in the adjuvant setting, for patients with clear cell renal cell carcinoma (RCC) following nephrectomy.
  • WELIREG in combination with KEYTRUDA QLEX (supplemental applications), June 19
    • Merck & Co
    • FDA decision on WELIREG in combination with KEYTRUDA QLEX given in the adjuvant setting, for patients with clear cell renal cell carcinoma following nephrectomy.
  • Cytisinicline (NDA), June 20
    • Achieve Life Sciences
    • FDA decision on Cytisinicline for the treatment for smoking cessation in adults.
  • Nanoecapsulated Sirolimus plus Pegadricase (BLA), June 27
    • Swedish Orphan Biovitrum
    • FDA decision on Nanoecapsulated Sirolimus plus Pegadricase (NASP) to treat uncontrolled gout.
  • ZORYVE cream 0.3% (sNDA), June 29
    • Arcutis Biotherapeutics
    • FDA decision on ZORYVE cream 0.3% to expand indication for the topical treatment of plaque psoriasis to include children 2 to 5 years old.
  • LNTH-2501 (NDA), June 29
    • Lantheus
    • FDA decision on LNTH-2501 for use with positron emission tomography (PET) imaging for localization of somatostatin receptor-positive (SSTR+) neuroendocrine tumors (NETs) in adult and pediatric patients.
  • Oxlanthanum Carbonate, June 29
    • Unicycive Therapeutics
    • FDA decision on Oxylanthanum Carbonate for the treatment of hyperphosphatemia in CKD patients on dialysis.
  • Olezarsen (NDA), June 30
    • Ionis Pharmaceuticals
    • FDA decision on Olezarsen for the treatment of severe hypertriglyceridemia.
  • Veligrotug (BLA), June 30
    • Viridian Therapeutics
    • FDA decision on Veligrotug for the Treatment of Thyroid Eye Disease.

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