Q3 2024 Upcoming FDA Decision Dates (PDUFAs)

As we move into the second half of 2024, following a hopeful uptick for the biotech industry in the first two quarters, it’s more important than ever to stay on top of the news in this ever-evolving industry. Some of the most crucial developments to keep up with are the approaching FDA approval dates, which provide insight into the industry’s outlook for the rest of the year.

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

 
DATE COMPANY NAME DRUG NAME USE/THERAPEUTIC AREA
01/3/2024 Checkpoint Therapeutics Cosibelimab Metastatic or Locally Advanced Cutaneous Squamous Cell Carcinoma
01/5/2024 Novan Berdazimer Gel, 10.3% Molluscum Contagiosum
01/12/2024 Astellas Olbetuximab Gastroesophageal junction (GEJ) adenocarcinoma
01/12/2024 Astellas Pharma Zolbetuximab Gastric Cancer
01/13/2024 GC Biopharma GC5107B Primary Humoral Immunodeficiency (PI)
01/17/2024 Merck WELIREG (belzutifan) Previously Treated Patients With Advanced Renal Cell Carcinoma (RCC)
01/20/2024 Merck Keytruda (pembrolizumab) Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
01/20/2024 Theratechnologies Tesamorelin F8 Formulation Reduction of excess abdominal fat in adults with HIV who have lipodystrophy
01/23/2024 Heron Therapeutics ZYNRELEF (bupivacaine and meloxicam) Post-Operative Pain
01/24/2024 Liquidia Corporation Yutrepia (treprostinil) Pulmonary Arterial Hypertension (PAH); Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD)
01/26/2024 Defender Pharmaceuticals scopolamine (DPI-386) Motion Sickness
01/31/2024 Sanofi and Regeneron Dupixent (dupilumab) Eosinophilic esophagitis (EoE)
01/31/2024 Vyluma NVK002 Myopia
02/13/2024 Ipsen Onivyde (irinotecan liposome injection) Metastatic pancreatic ductal adenocarcinoma
02/22/2024 Venatorx Pharmaceuticals cefepime-taniborbactam Complicated Urinary Tract Infections (cUTI), including Pyelonephritis
02/24/2024 Iovance Biotherapeutics Lifileucel Advanced Melanoma
02/24/2024 Alvotech AVT02 Inflammatory diseases including rheumatoid arthritis
02/26/2024 Minerva Neurosciences Roluperidone Schizophrenia- Negative Symptoms
03/4/2024 Eyenovia APP13007 Post-operative inflammation and pain following ocular surgery
03/4/2024 Vanda Pharmaceuticals HETLIOZ (tasimelteon) Non-24-Hour Sleep-Wake Disorder (Non-24) in adults
03/8/2024 Viatris and Mapi Pharma Copaxone (Glatiramer Acetate Depot) Relapsed forms of multiple sclerosis (MS)
03/13/2024 Mirum Pharmaceuticals Livmarli (maralixibat) Cholestatic pruritus in patients with progressive familial intrahepatic cholestasis (PFIC)
03/14/2024 Madrigal Pharmaceuticals Resmetirom Nonalcoholic steatohepatitis (NASH)
03/14/2024 Bristol Myers Squibb Breyanzi (lisocabtagene maraleucel) Relapsed/refractory large B-cell lymphoma (LBCL)
03/16/2024 Optinose XHANCE Chronic rhinosinusitis with nasal polyps (CRSwNP)
03/18/2024 Orchard Therapeutics OTL-200 Metachromatic leukodystrophy (MLD)
03/21/2024 Italfarmaco Group Givinostat Duchenne Muscular Dystrophy (DMD)
03/23/2024 Incyte ruxolitinib myelofibrosis, polycythemia vera, and graft vs. host disease (GVHD)
03/26/2024 Merck Sotatercept Pulmonary arterial hypertension (PAH)
03/27/2024 Akebia Therapeutics Vadadustat Anemia in patients with CKD undergoing dialysis
03/27/2024 Esperion NEXLETOL (bempedoic acid) Lowers the level of cholesterol in the blood
03/30/2024 Vertex and CRISPR Therapeutics Casgevy (exagamglogene autotemcel) Severe Sickle Cell Disease and Transfusion-Dependent Beta Thalassemia
03/31/2024 Rocket Pharmaceuticals RP-L201 (marnetegragene autotemcel) Leukocyte adhesion deficiency-I (LAD-I)
03/31/2024 Regeneron Pharmaceuticals Odronextamab (REGN1979) Relapsed/refractory follicular lymphoma or relapsed/refractory diffuse large B-cell lymphoma (DLBCL)
04/01/2024 AstraZeneca Voydeya (danicopan) Extravascular hemolysis in adults with paroxysmal nocturnal hemoglobinuria (PNH)
04/02/2024 Vanda Pharmaceuticals Fanapt Manic or mixed episodes associated with bipolar I disorder in adults
04/03/2024 Basilea Pharmaceutica AG ZEVTERA (Ceftobiprole) SAB infections and ABSSSI in adults and for CABP in adults and pediatric patients
04/04/2024 Bristol Myers Squibb & 2seventy Bio Abecma (idecabtagene vicleucel; ide-cel) Triple-Class Exposed Relapsed or Refractory Multiple Myeloma After Two Prior Lines of Therapy
04/05/2024 Janssen & Legend Biotech Carvykti (ciltacabtagene autoleucel; cilta-cel) Relapsed or refractory multiple myeloma
04/05/2024 Bristol Myers Squibb Opdivo (nivolumab) Unresectable or metastatic urothelial carcinoma
04/05/2024 Supernus Pharmaceuticals SPN-830 Motor fluctuations (OFF episodes) in Parkinson’s disease
04/05/2024 AbbVie/Immunogen ELAHERE Platinum-Resistant Ovarian Cancer
04/23/2024 ImmunityBio N-803 BCG-unresponsive non-muscle invasive bladder carcinoma (NMIBC)
04/28/2024 Aquestive Therapeutics Libervant (diazepam) Buccal Film Seizure clusters in patients between two and five years of age
04/29/2024 PharmaTher KETARX (Ketamine) Mental health, neurological and pain disorders
04/30/2024 Day One Biopharmaceuticals Tovorafenib Relapsed or progressive pediatric low-grade glioma (pLGG)
04/30/2024 X4 Pharmaceuticals Mavorixafor WHIM (Warts, Hypogammaglobulinemia, Infections, and Myelokathexis) syndrome
04/30/2024 Neurocrine Biosciences Inc INGREZZA (valbenazine) Tardive dyskinesia and chorea associated with Huntington’s disease
05/09/2024 Astellas Pharma Inc. PADCEV (enfortumab vedotin-ejfv) Advanced Bladder Cancer
05/09/2024 Merck KEYTRUDA (pembrolizumab) Plus Padcev (enfortumab vedotin-ejfv) Locally advanced or metastatic urothelia
05/09/2024 Pfizer & GENMAB Tivdak Recurrent or Metastatic Cervical Cancer
05/13/2024 Dynavax Technologies Corp HEPLISAV-B Infection caused by all known subtypes of hepatitis B virus
05/14/2024 Ascendis Pharma TransCon PTH (Palopegteriparatide) Hypoparathyroidism
05/23/2024 Bristol Myers Squibb Breyanzi (lisocabtagene maraleucel) Relapsed or refractory follicular lymphoma (FL)
05/25/2024 Abeona Therapeutics Pz-cel Recessive dystrophic epidermolysis bullosa
05/30/2024 Daiichi Sankyo & AstraZeneca Enhertu (trastuzumab deruxtecan) Unresectable or Metastatic HER2 Positive Solid Tumors
05/31/2024 Bristol Myers Squibb Breyanzi (lisocabtagene maraleucel) Relapsed or refractory mantle cell lymphoma (MCL)
06/04/2024 Catalyst Pharmaceutical Firdapse (amifampridine) Lambert-Eaton myasthenic syndrome (“LEMS”)
06/07/2024 GSK AREXVY (RSV Vaccine) Prevention of RSV disease in adults aged 50-59 at increased risk
06/10/2024 Ipsen and GENFIT Elafibranor Rare cholestatic liver disease, primary biliary cholangitis (PBC)
06/12/2024 Amgen Tarlatamab Advanced small cell lung cancer (SCLC)
06/15/2024 Bristol-Myers Squibb Augtyro (repotrectinib) NTRK-Positive Locally Advanced or Metastatic Solid Tumors
06/16/2024 Geron Corporation Imetelstat Lower risk myelodysplastic syndromes (MDS)
06/17/2024 Merck & Ligand Pharmaceuticals V116 Prevent of invasive pneumococcal disease and pneumococcal pneumonia
06/21/2024 Sarepta Therapeutics ELEVIDYS (delandistrogene moxeparvovec-rokl) Duchenne muscular dystrophy (DMD)
06/21/2024 Argenx VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) Chronic inflammatory demyelinating polyneuropathy (CIDP)
06/21/2024 Merck & Co Inc. KEYTRUDA (pembrolizumab) Advanced endometrial cancer
06/21/2024 Bristol-Myers Squibb KRAZATI (adagrasib) KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC)
06/21/2024 Harmony Biosciences WAKIX (pitolisant) Excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy
06/26/2024 Merck & Daiichi Sankyo Patritumab deruxtecan (HER3-DXd) Locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) previously treated with two or more systemic therapies
06/26/2024 Verona Pharma plc Ensifentrine Asthma and chronic obstructive pulmonary disease (COPD)
06/27/2024 Sanofi Dupixent (dupilumab) Chronic obstructive pulmonary disease (COPD) with type 2 inflammation
06/28/2024 AbbVie & GENMAB EPKINLY (Epcoritamab-bysp) Elapsed or Refractory Follicular Lymphoma (FL)
06/30/2024 Rocket Pharmaceuticals RP-L201 (marnetegragene autotemcel) Leukocyte adhesion deficiency-I (LAD-I)
07/7/2024 Arcutis Biotherapeutics Inc. Roflumilast Cream 0.15% Atopic Dermatitis in Adults and Children Down to Age 6
07/15/2024 Orexo AB OX124 opioid overdose
07/19/2024 Phathom Pharmaceuticals Inc VOQUEZNA (vonoprazan) Tablets Heartburn associated with Non-Erosive GERD
07/25/2024 AstraZeneca IMFINZI Resectable non-small cell lung cancer
07/27/2024 Alpha Cognition Inc. ALPHA-1062 Mild-to-moderate Alzheimer’s disease in U.S.
07/31/2024 Xspray Pharma Dasynoc (dasatinib amorphous) Chronic myeloid leukemia (CML)
08/4/2024 Adaptimmune Therapeutics Afami-cel Advanced synovial sarcoma
08/10/2024 Humacyte, Inc. Human Acellular Vessel Vascular trauma
08/13/2024 Citius Pharmaceuticals LYMPHIR (denileukin diftitox) Relapsed or refractory cutaneous T-cell lymphoma (CTCL)
08/14/2024 Ascendis Pharma TransCon PTH (palopegteriparatide) Hypoparathyroidism
08/14/2024 Gilead Sciences Seladelpar Primary Biliary Cholangitis (PBC)
08/20/2024 Royal Pharma vorasidenib IDH-mutant glioma
08/22/2024 Regeneron Pharmaceuticals Linvoseltamab Relapsed/refractory (R/R) multiple myeloma (MM)
08/23/2024 GSK Jemperli (dostarlimab) Primary advanced or recurrent endometrial cancer
08/28/2024 Incyte Corporation / Syndax Pharmaceuticals Axatilimab Chronic Graft-Versus-Host Disease
09/5/2024 Travere Therapeutics / Ligand Pharmaceuticals Filspari (sparsentan) IgA Nephropathy
09/7/2024 AVADEL PHARMACEUTICALS LUMRYZ Cataplexy or EDS in the pediatric narcolepsy population
09/18/2024 VANDA PHARMACEUTICALS Tradipitant Gastroparesis
09/21/2024 Zevra Therapeutics / XOMA Corporation Arimoclomol Niemann-Pick disease type C
09/23/2024 Heron Therapeutics ZYNRELEF Instillation to produce postsurgical analgesia for up to 72 hours after soft tissue and orthopedic procedures
09/24/2024 IntraBio IB1001 (N-acetyl-L-leucine) Niemann-Pick disease Type C (NPC)
09/25/2024 Merck KEYTRUDA (pembrolizumab) Unresectable Advanced or Metastatic Malignant Pleural Mesothelioma
09/26/2024 Syndax Pharmaceuticals Revumenib Relapsed or refractory (R/R) KMT2A-rearranged (KMT2Ar) acute leukemia
09/26/2024 Bristol-Myers Squibb KarXT Schizophrenia in adults
09/27/2024 Regeneron Pharmaceuticals / Sanofi Dupixent Chronic obstructive pulmonary disease (COPD) with type 2 inflammation
09/27/2024 Sanofi Sarclisa (isatuximab-irfc) in combination with bortezomib, lenalidomide, and dexamethasone treatment of transplant-ineligible newly diagnosed multiple myeloma
Q2 2024 Pfizer Fidanacogene elaparvovec Hemophilia B
Q2 2024 BeiGene Beukina (zanubrutinib) Relapsed or refractory follicular lymphoma
Q2 2024 Roche XOLAIR (omalizumab) Asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), chronic spontaneous urticaria (CSU)
Q2 2024 AstraZeneca TAGRISSO (osimertinib) Non-small cell lung cancer (NSCLC)
Q2 2024 AstraZeneca FluMist Quadrivalent Active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.

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