United States Food and Drug Administration
FDA Memo Claims COVID Vaccine Linked to 10 Child Deaths, Faces Expert Skepticism and Criticism
FDA memo; COVID vaccine; child deaths; Vinay Prasad; VAERS; vaccine safety
Alumis’ TYK2 Inhibitor Envudeucitinib Succeeds in Phase 3 Psoriasis Trials, Plans FDA Filing
Alumis; envudeucitinib; TYK2 inhibitor; psoriasis; Phase 3 trials; FDA approval; PASI 75
Protara Therapeutics Receives FDA Breakthrough Therapy and Fast Track Designations for TARA-002 in Pediatric Lymphatic Malformations
Protara Therapeutics; TARA-002; FDA; Breakthrough Therapy; Fast Track; Lymphatic Malformations; Pediatric
Bayer Receives Breakthrough Therapy Designation in US and China for Sevabertinib in First-Line HER2-Mutant NSCLC
Bayer; sevabertinib; Breakthrough Therapy Designation; HER2-mutant NSCLC; FDA; China CDE; first-line treatment
Spotlight On: Five key oncology stories to watch in 2026
oncology 2026; cancer research trends; FDA oncology decisions 2026; antibody-drug conjugates; radiopharmaceuticals; liquid biopsy; mRNA cancer vaccines; AI in oncology; cell therapies CAR-T TIL TCR; precision oncology
FDA Clears BrainSpace Intellidrop: Automated Neuro Device Tackling ICU Nursing Shortages and Advancing Physical AI
FDA clearance; BrainSpace; Intellidrop; ICU nursing shortages; brain fluid management; Physical AI; neuro injury
ScinoPharm Taiwan Secures Historic U.S. FDA Approval for Glatiramer Acetate Injection to Treat Multiple Sclerosis
ScinoPharm; FDA Approval; Glatiramer Acetate; Multiple Sclerosis; Taiwan; Complex Generic
FDA Rejects Relacorilant for Cushing’s Syndrome High Blood Pressure
FDA; relacorilant; Cushing’s syndrome; Corcept Therapeutics; rejection; high blood pressure
Vanda Pharmaceuticals Secures FDA Approval for NEREUS (Tradipitant), First New Motion Sickness Drug in Over 40 Years
Vanda Pharmaceuticals; FDA approval; NEREUS; tradipitant; motion sickness; vomiting prevention
Agios Pharmaceuticals Secures FDA Approval for Aqvesme (Mitapivat) in Thalassemia Treatment
Agios Pharmaceuticals; FDA approval; thalassemia; Aqvesme; mitapivat; anemia