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 |
| 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) |
| Q2 2024 | Pfizer | Fidanacogene elaparvovec | Hemophilia B |
