As we head into a busy holiday season and look towards 2025, it’s important to stay up-to-date on the news in the ever-evolving biotech industry. During a year of transition such as 2024, the remaining FDA approval dates this year have the potential to solidify trends and shape the outlook for the industry in 2025.
Read on for an overview of the FDA’s upcoming decision dates for new drug approvals in the remainder of 2024.
| DATE | COMPANY NAME | DRUG NAME | USE/THERAPEUTIC AREA |
| 10-04-2024 | Biofrontera | Ameluz | Actinic keratosis (AK) |
| 10-08-2024 | Bristol Myers Squibb | Neoadjuvant nivolumab (Opdivo) | IIA to IIIB non–small cell lung cancer (NSCLC) |
| 10-08-2024 | Zealand Pharma | Dasiglucagon | Hypoglycemia in Congenital Hyperinsulinism |
| 10-11-2024 | Pfizer | Hympavzi (marstacimab-hncq) | Hemophilia A or B without inhibitors |
| 10-15-2024 | Intercept Pharmaceuticals | Ocaliva (obeticholic acid) | Primary biliary cholangitis (PBC) |
| 10-17-2024 | Avadel Pharmaceuticals | Lumryz (sodium oxybate) | Cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. |
| 10-21-2024 | Camurus | Oclaiz (CAM2029) | Acromegaly |
| 10-25-2024 | Iterum Therapeutics | ORLYNVAH™ (Oral Sulopenem) | Uncomplicated Urinary Tract Infections |
| 10-29-2024 | Novartis | Asciminib (Scemblix) | Chronic myeloid leukemia |
| 11-4-2024 | Journey Medical Corporation | DFD-29 (minocycline hydrochloride) | Inflammatory lesions and erythema of rosacea |
| 11-13-2024 | PTC Therapeutics | Upstaza (eladocagene exuparvovec) | Aromatic L–amino Acid Decarboxylase (AADC) deficiency |
| 11-16-2024 | Autolus Therapeutics | Obecabtagene autoleucel (obe-cel) | Relapsed/refractory adult B-cell acute lymphoblastic leukemia (ALL) |
| 11-27-2024 | Roche | Inavolisib | HR+/HER2– PIK3CA+ Breast Cancer |
| 11-28-2024 | Applied Therapeutics Inc. | Govorestat (AT-007) | Galactosemia type 1 |
| 11-29-2024 | Zymeworks & Jazz Pharmaceuticals | Zanidatamab | HER2-Positive Metastatic Biliary Tract Cancer |
| 11-29-2024 | BridgeBio Pharma | Acoramidis | Transthyretin Amyloid Cardiomyopathy (ATTR-CM) |
| 11-30-2024 | Shorla Oncology | SH-201 | Leukemia and other cancers. |
| 12-19-2024 | Ionis Pharmaceuticals | Olezarsen | Familial chylomicronemia syndrome |
| 12-20-2024 | Lexicon Pharmaceutical | Zynquista (sotagliflozin) | Type 1 Diabetes and chronic kidney disease |
| 12-26-2024 | Rhythm Pharmaceuticals | Imcivree (setmelanotide) | Bardet-Biedl syndrome or POMC/LEPR deficiency |
| 12-26-2024 | Syndax Pharma | Revumenib | Relapsed or refractory (R/R) KMT2A-rearranged (KMT2Ar) acute leukemia |
| 12-27-2024 | Soleno Therapuetics | DCCR (Diazoxide Choline) | Prader-Willi Syndrome (PWS) |
| 12-28-2024 | Checkpoint Therapeutics | Cosibelimab | Advanced Cutaneous Squamous Cell Carcinoma |
| 12-28-2024 | Xcovery Holdings | Ensartinib | Anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) |
| 12-29-2024 | Halozyme Therapeutics & Bristol Myers Squibb | Opdivo (nivolumab) | Advanced or Metastatic Solid Tumors |
| 12-30-2024 | Neurocrine Biosciences | Crinecerfont | Congenital adrenal hyperplasia (CAH) |
| Dec 2024 | BeiGene | Tevimbra (tislelizumab) | Unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma |
| Q4 2024 | AstraZeneca | Tagrisso (osimertinib) | Stage III EGFR-mutated lung cancer |
