United States Food and Drug Administration – Page 3

Sanofi calls FDA rejection of potential MS blockbuster tolebrutinib “unexpected” amid evolving agency views on benefit–risk

2 weeks ago talkbio0Tagged BTK inhibitor, Complete Response Letter, DILI, Mississippi (geographic location), Multiple Sclerosis, nrSPMS, PERSEUS trial, perspectives, Progressive, Rejection, sanofi, Tolebrutinib, United States Food and Drug Administration

Sanofi; tolebrutinib; multiple sclerosis; nrSPMS; BTK inhibitor; FDA rejection; complete response letter; DILI; primary progressive MS; Perseus trial; evolving FDA perspectives

FDA Memo Claims COVID Vaccine Linked to 10 Child Deaths, Faces Expert Skepticism and Criticism

2 weeks ago talkbio0Tagged COVID, Death of child, MEMO1 gene, United States Food and Drug Administration, Vaccine Safety, Vaccines, VAERS, Vinay Prasad

FDA memo; COVID vaccine; child deaths; Vinay Prasad; VAERS; vaccine safety

Alumis’ TYK2 Inhibitor Envudeucitinib Succeeds in Phase 3 Psoriasis Trials, Plans FDA Filing

2 weeks ago talkbio0Tagged Alumis, Approved, envudeucitinib, Phase 3 trials, Psoriasis, Psoriasis Area and Severity Index Clinical Classification, TYK2 Inhibitor, United States Food and Drug Administration

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

2 weeks ago talkbio0Tagged Breakthrough Therapy, Fast Track, Lymphatic Abnormalities, Lyophilized Inactivated Group A Streptococcus TARA-002, Pediatric brand name, Protara Therapeutics, United States Food and Drug Administration

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

2 weeks ago talkbio0Tagged Bayer, Breakthrough Therapy Designation, CDE, China, First line treatment, HER2-mutant, Non-Small Cell Lung Carcinoma, sevabertinib, United States Food and Drug Administration

Bayer; sevabertinib; Breakthrough Therapy Designation; HER2-mutant NSCLC; FDA; China CDE; first-line treatment

Spotlight On: Five key oncology stories to watch in 2026

2 weeks ago talkbio0Tagged 2026, Antibody-Drug Conjugates, cancer research trends, CAR-T, Cell Therapy, Liquid Biopsy, Lymphocytes, Tumor-Infiltrating, mRNA cancer, Neoplasms, oncology decisions, precision oncology, Radiopharmaceuticals, T-Cell Receptor, United States Food and Drug Administration, Vaccines

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