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) |
