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. |