United States Food and Drug Administration – Page 3

FDA Rejects Stealth BioTherapeutics’ Rare Disease Drug but Leaves Door Open for Accelerated Approval

2 weeks ago talkbio0Tagged 3-Methylglutaconic aciduria type 2, Accelerated, Approved, Elamipretide, Infrequent, muscle strength endpoint, Phase 2 trial, regulatory delay, Rejection, Stealth BioTherapeutics, United States Food and Drug Administration

FDA rejection; Stealth BioTherapeutics; elamipretide; Barth syndrome; rare disease; accelerated approval; muscle strength endpoint; phase 2 trial; regulatory delay

Merck, Daiichi Sankyo Withdraw FDA Application for HER3-Targeting ADC After Survival Endpoint Miss

2 weeks ago talkbio0Tagged Application procedure, Clinical Trials, Daiichi, Deruxtecan, HER3, Merck, Non-Small Cell Lung Carcinoma, Overall Survival, patritumab, Sankyo, therapeutic autologous dendritic cells, United States Food and Drug Administration, Withdraw (activity)

Merck; Daiichi Sankyo; patritumab deruxtecan; HER3 ADC; FDA application; non-small cell lung cancer; clinical trial; overall survival; application withdrawal

Uncertainty Surrounds Moderna’s Next-Generation COVID Shot Amid Policy Changes

2 weeks ago talkbio0Tagged COVID19 (disease), flu/COVID-19, Moderna, Policy, Recommendation, Regulatory Setback, United States Food and Drug Administration, vaccine access, Vaccines

Moderna; COVID-19 vaccine; FDA policy; combination flu/COVID-19 shot; vaccine access; mRNA-1083; vaccine recommendations; regulatory setback

GSK, Spero Report Major Phase 3 Win for UTI Antibiotic; Spero’s Stock Surges

2 weeks ago talkbio0Tagged Antibiotics, Clinical Trials, Complicated, HBr, PIVOT-PO trial, SmithKline Beecham, Spero Therapeutics, Stock Surge, Submission, United States Food and Drug Administration, Urinary tract infection

GSK; Spero Therapeutics; tebipenem HBr; Phase 3 trial; UTI antibiotic; complicated urinary tract infection; PIVOT-PO trial; stock surge; clinical trial results; FDA submission

A New Dawn for Psychedelics: Compass Pathways Nears Major Phase 3 Psilocybin Results

2 weeks ago talkbio0Tagged Breakthrough Therapy, COMP360, Compass Pathways, mental health innovation, Psilocybin, psychedelic therapy, treatment-resistant depression, United States Food and Drug Administration

Compass Pathways; COMP360; psilocybin; treatment-resistant depression; phase 3 trial; psychedelic therapy; FDA Breakthrough Therapy; mental health innovation

Patient Death in Rocket Pharmaceuticals Gene Therapy Trial Prompts FDA Clinical Hold

3 weeks ago talkbio0Tagged acute systemic infection, Adverse event, Capillary Leak Syndrome, gene therapy, Glycogen Storage Disease Type IIb, Patient Death, Rocket, RP-A501, Study on Hold, United States Food and Drug Administration

Rocket Pharmaceuticals; gene therapy; Danon disease; clinical hold; FDA; patient death; capillary leak syndrome; acute systemic infection; RP-A501; adverse event