United States Food and Drug Administration
FDA Approves Ensartinib for First-Line Treatment of ALK-Positive NSCLC
Ensartinib, ALK-positive NSCLC, FDA approval, lung cancer treatment, Xcovery Holdings
FDA Rejects Subcutaneous Version of J&J’s Lung Cancer Drug Rybrevant Due to Manufacturing Concerns
FDA rejection, J&J, Subcutaneous Rybrevant, Manufacturing issues, Lung cancer drug, Non-small cell lung cancer (NSCLC), Epidermal growth factor receptor (EGFR) mutations
Regeneron’s EYLEA HD Succeeds in Phase 3 Trial for Retinal Vein Occlusion, Paving Way for 2025 FDA Submission
EYLEA HD, Aflibercept, Retinal Vein Occlusion (RVO), Phase 3 QUASAR Trial, Extended Dosing Intervals, FDA Submission 2025, Regeneron Pharmaceuticals
FDA Declines Approval for J&J’s Subcutaneous Rybrevant and AstraZeneca’s Full Approval Bid for Andexxa
FDA, J&J, Rybrevant, AstraZeneca, Andexxa, regulatory review, pharmaceuticals
FDA Rejects Full Approval for AstraZeneca’s Andexxa Amid Safety Concerns
Andexxa, AstraZeneca, FDA, full approval, safety concerns, bleeding reversal agent, FXa inhibitors
FDA Approves Neurocrine’s Crenessity for Rare Congenital Adrenal Hyperplasia
Neurocrine Biosciences, FDA approval, Crenessity, crinecerfont, congenital adrenal hyperplasia (CAH), rare genetic disease, adrenal gland condition.
FDA Approves Expanded Use of VTAMA and Nemluvio for Atopic Dermatitis Treatment
FDA approval, atopic dermatitis, VTAMA, Nemluvio, Galderma, Organon, dermatology, skin conditions
FDA Places Clinical Hold on PepGen’s Duchenne Muscular Dystrophy Trial
FDA, Clinical Hold, PepGen, Duchenne Muscular Dystrophy, PGN-EDO51, CONNECT2-EDO51
FDA Approves UNLOXCYT for Advanced Cutaneous Squamous Cell Carcinoma, Marking a New Era in Skin Cancer Treatment
UNLOXCYT, cosibelimab-ipdl, FDA approval, advanced cutaneous squamous cell carcinoma (cSCC), checkpoint inhibitor, immunotherapy, skin cancer treatment.
FDA Halts Pediatric RSV Vaccine Trials Due to Safety Concerns
RSV vaccines, pediatric trials, safety concerns, FDA hold, VAERD risk