FDA News

Officials with the FDA have granted accelerated approval to datopotamab deruxtecan-dlnk (Datroway) for adults with locally advanced or metastatic EGFR-mutated non–small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy. Read More ›

On August 6, 2025, officials with the FDA granted accelerated approval to dordaviprone (Modeyso), a protease activator, for adult and pediatric patients aged ≥1 year with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy. Read More ›

The FDA has approved Novavax’s Nuvaxovid vaccine, which includes a proprietary adjuvant for prolonged immunization and response against severe acute SARS-CoV-2 based on study data that were captured from approximately 17,000 adults. Read More ›

Officials with the FDA recently approved a next-generation mRNA COVID-19 vaccine (mNexspike; Moderna) for vaccination against severe acute SARS-CoV-2. Read More ›

The FDA has approved clesrovimab-cfor (Enflonsia; Merck) for the prevention of respiratory syncytial virus (RSV)-associated lower respiratory tract infection. Read More ›

In June, officials with Sanofi and Regeneron announced that dupilumab (Dupixent) had been greenlit for the treatment of adult patients living with bullous pemphigoid (BP). Read More ›

Officials with the FDA approved roflumilast (Zoryve; Arcutis) foam 0.3% as a once-daily topical treatment for plaque psoriasis in adults and adolescents aged ≥12 years. Read More ›

The FDA has approved prademagene zamikeracel (Zevaskyn; Abeona Therapeutics), also known as pz-cel, as the first and only autologous cell-based gene therapy for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB), a serious and debilitating genetic skin disease. Read More ›

Officials with the FDA have approved the new drug application for the only hydrocortisone oral solution (Khindivi, Eton Pharmaceuticals) as a replacement therapy in pediatric patients 5 years of age and older with adrenocortical insufficiency. Read More ›

The FDA has approved penpulimab-kcqx (Akeso Biopharma Co, Ltd) with cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC) and as a single agent for adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and at least 1 other previous line of therapy. Read More ›