Q2 2024 Upcoming FDA Decision Dates (PDUFAs)

When you work in an industry as rapidly changing as biotechnology, it’s crucial to stay up to date. Awareness of the FDA’s new drug approval dates is especially crucial: the decisions put forth on these dates can significantly affect the outlook of the companies involved, and these ramifications often reverberate through the industry as a whole.

Read on for a rundown of the FDA’s upcoming decision dates for new drug approvals in the first quarter of 2024.

04/01/2024AstraZenecaVoydeya (danicopan)Extravascular hemolysis in adults with paroxysmal nocturnal hemoglobinuria (PNH)
04/02/2024Vanda PharmaceuticalsFanaptManic or mixed episodes associated with bipolar I disorder in adults
04/03/2024Basilea Pharmaceutica AGZEVTERA (Ceftobiprole)SAB infections and ABSSSI in adults and for CABP in adults and pediatric patients
04/04/2024Bristol Myers Squibb & 2seventy BioAbecma (idecabtagene vicleucel; ide-cel)Triple-Class Exposed Relapsed or Refractory Multiple Myeloma After Two Prior Lines of Therapy
04/05/2024Janssen & Legend BiotechCarvykti (ciltacabtagene autoleucel; cilta-cel)Relapsed or refractory multiple myeloma
04/05/2024Bristol Myers SquibbOpdivo (nivolumab)Unresectable or metastatic urothelial carcinoma
04/05/2024Supernus PharmaceuticalsSPN-830Motor fluctuations (OFF episodes) in Parkinson’s disease
04/05/2024AbbVie/ImmunogenELAHEREPlatinum-Resistant Ovarian Cancer
04/23/2024ImmunityBioN-803BCG-unresponsive non-muscle invasive bladder carcinoma (NMIBC)
04/28/2024Aquestive TherapeuticsLibervant (diazepam) Buccal FilmSeizure clusters in patients between two and five years of age
04/29/2024PharmaTherKETARX (Ketamine)Mental health, neurological and pain disorders
04/30/2024Day One BiopharmaceuticalsTovorafenibRelapsed or progressive pediatric low-grade glioma (pLGG)
04/30/2024X4 PharmaceuticalsMavorixaforWHIM (Warts, Hypogammaglobulinemia, Infections, and Myelokathexis) syndrome
04/30/2024Neurocrine Biosciences IncINGREZZA (valbenazine)Tardive dyskinesia and chorea associated with Huntington’s disease
05/09/2024Astellas Pharma Inc.PADCEV (enfortumab vedotin-ejfv)Advanced Bladder Cancer
05/09/2024MerckKEYTRUDA (pembrolizumab) Plus Padcev (enfortumab vedotin-ejfv)Locally advanced or metastatic urothelia
05/09/2024Pfizer & GENMABTivdakRecurrent or Metastatic Cervical Cancer
05/13/2024Dynavax Technologies CorpHEPLISAV-BInfection caused by all known subtypes of hepatitis B virus
05/14/2024Ascendis PharmaTransCon PTH (Palopegteriparatide)Hypoparathyroidism
05/23/2024Bristol Myers SquibbBreyanzi (lisocabtagene maraleucel)Relapsed or refractory follicular lymphoma (FL)
05/25/2024Abeona TherapeuticsPz-celRecessive dystrophic epidermolysis bullosa
05/30/2024Daiichi Sankyo & AstraZenecaEnhertu (trastuzumab deruxtecan)Unresectable or Metastatic HER2 Positive Solid Tumors
05/31/2024Bristol Myers SquibbBreyanzi (lisocabtagene maraleucel)Relapsed or refractory mantle cell lymphoma (MCL)
06/04/2024Catalyst PharmaceuticalFirdapse (amifampridine)Lambert-Eaton myasthenic syndrome (“LEMS”)
06/07/2024GSKAREXVY (RSV Vaccine)Prevention of RSV disease in adults aged 50-59 at increased risk
06/10/2024Ipsen and GENFITElafibranorRare cholestatic liver disease, primary biliary cholangitis (PBC)
06/12/2024AmgenTarlatamabAdvanced small cell lung cancer (SCLC)
06/15/2024Bristol-Myers SquibbAugtyro (repotrectinib)NTRK-Positive Locally Advanced or Metastatic Solid Tumors
06/16/2024Geron CorporationImetelstatLower risk myelodysplastic syndromes (MDS)
06/17/2024Merck & Ligand PharmaceuticalsV116Prevent of invasive pneumococcal disease and pneumococcal pneumonia
06/21/2024Sarepta TherapeuticsELEVIDYS (delandistrogene moxeparvovec-rokl)Duchenne muscular dystrophy (DMD)
06/21/2024ArgenxVYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc)Chronic inflammatory demyelinating polyneuropathy (CIDP)
06/21/2024Merck & Co Inc.KEYTRUDA (pembrolizumab)Advanced endometrial cancer
06/21/2024Bristol-Myers SquibbKRAZATI (adagrasib)KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC)
06/21/2024Harmony BiosciencesWAKIX (pitolisant)Excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy
06/26/2024Merck & Daiichi SankyoPatritumab deruxtecan (HER3-DXd)Locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) previously treated with two or more systemic therapies
06/26/2024Verona Pharma plcEnsifentrineAsthma and chronic obstructive pulmonary disease (COPD)
06/27/2024SanofiDupixent (dupilumab)Chronic obstructive pulmonary disease (COPD) with type 2 inflammation
06/28/2024AbbVie & GENMABEPKINLY (Epcoritamab-bysp)Elapsed or Refractory Follicular Lymphoma (FL)
06/30/2024Rocket PharmaceuticalsRP-L201 (marnetegragene autotemcel)Leukocyte adhesion deficiency-I (LAD-I)
Q2 2024PfizerFidanacogene elaparvovecHemophilia B

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