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.

DATE COMPANY NAME DRUG NAME USE/THERAPEUTIC AREA
01/20/2024 Merck Keytruda (pembrolizumab) Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
01/22/2024 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)
1/26/2024 Defender Pharmaceuticals scopolamine (DPI-386) Motion Sickness
1/31/2024 Sanofi and Regeneron Dupixent (dupilumab) Eosinophilic esophagitis (EoE)
1/31/2024 Vyluma NVK002 Myopia
2/13/2024 Ipsen Onivyde (irinotecan liposome injection) Metastatic pancreatic ductal adenocarcinoma
2/22/2024 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
3/4/2024 Eyenovia APP13007 Post-operative inflammation and pain following ocular surgery
3/4/2024 Vanda Pharmaceuticals HETLIOZ (tasimelteon) Non-24-Hour Sleep-Wake Disorder (Non-24) in adults
03/08/2024 Viatris and Mapi Pharma Copaxone (Glatiramer Acetate Depot) Relapsed forms of multiple sclerosis (MS)
3/13/2024 Mirum Pharmaceuticals Livmarli (maralixibat) Cholestatic pruritus in patients with progressive familial intrahepatic cholestasis (PFIC)
3/14/2024 Madrigal Pharmaceuticals Resmetirom Nonalcoholic steatohepatitis (NASH)
3/14/2024 Bristol Myers Squibb Breyanzi (lisocabtagene maraleucel) Relapsed/refractory large B-cell lymphoma (LBCL)
3/16/2024 Optinose XHANCE Chronic rhinosinusitis with nasal polyps (CRSwNP)
3/18/2024 Orchard Therapeutics OTL-200 Metachromatic leukodystrophy (MLD)
3/21/2024 Italfarmaco Group Givinostat Duchenne Muscular Dystrophy (DMD)
3/23/2024 Incyte ruxolitinib myelofibrosis, polycythemia vera, and graft vs. host disease (GVHD)
3/26/2024 Merck Sotatercept Pulmonary arterial hypertension (PAH)
3/27/2024 Akebia Therapeutics Vadadustat Anemia in patients with CKD undergoing dialysis
3/27/2024 Esperion NEXLETOL (bempedoic acid) Lowers the level of cholesterol in the blood
3/30/2024 Vertex and CRISPR Therapeutics Casgevy (exagamglogene autotemcel) Severe Sickle Cell Disease and Transfusion-Dependent Beta Thalassemia
3/31/2024 Rocket Pharmaceuticals RP-L201 (marnetegragene autotemcel) Leukocyte adhesion deficiency-I (LAD-I)
3/31/2024 Regeneron Pharmaceuticals Odronextamab (REGN1979) Relapsed/refractory follicular lymphoma or relapsed/refractory diffuse large B-cell lymphoma (DLBCL)

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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...

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