Browsing Tag
U.S. Food and Drug Administration
103 posts
Gene therapy dreams on hold? Inside the FDA move that rattled Tenaya Therapeutics
Find out why the FDA paused Tenaya’s TN-201 trial for heart disease and what this could mean for gene therapy investors and the company’s future.
Regeneron’s Libtayo wins FDA approval as first adjuvant immunotherapy for high-risk skin cancer patients
Find out how Regeneron’s Libtayo is redefining skin cancer care as the first FDA-approved adjuvant immunotherapy for high-risk CSCC patients
How Spruce Biosciences’ tralesinidase alfa could become the first disease-modifying therapy for Sanfilippo syndrome type B
Find out how Spruce Biosciences is redefining enzyme replacement therapy with its FDA-designated tralesinidase alfa for Sanfilippo syndrome type B.
Liquid biopsy breakthrough: FDA okays Guardant360 CDx to match patients to Eli Lilly’s Inluriyo
FDA approves Guardant360 CDx as a companion diagnostic for Inluriyo in ESR1-mutated breast cancer. Discover how liquid biopsy is reshaping oncology care today.
Johnson & Johnson wins FDA approval for Tremfya in pediatric psoriasis and psoriatic arthritis
Johnson & Johnson wins FDA approval for Tremfya in pediatric psoriasis and psoriatic arthritis, extending its immunology lead and boosting growth prospects.
Novo Nordisk seeks FDA nod for Mim8 — how will this impact hemophilia treatment and NVO stock?
Novo Nordisk files FDA application for Mim8 in hemophilia A. Learn how flexible dosing and trial data could redefine the bleeding disorder market.
Eli Lilly wins FDA approval for Inluriyo in ESR1-mutated metastatic breast cancer
FDA approves Eli Lilly’s Inluriyo for ESR1-mutated breast cancer, boosting oncology pipeline and investor confidence. Learn how this reshapes treatment.
Island Pharmaceuticals stock climbs as FDA clears path for Galidesivir fast-track review
Island Pharmaceuticals (ASX: ILA) stock rises as FDA fast-tracks Galidesivir under the Animal Rule, with survival data, PRV potential, and stockpile contracts in focus.
Thryv Therapeutics secures FDA IND clearance to launch first potential drug for Long QT syndrome
Thryv Therapeutics gains FDA IND clearance for THRV-1268 in Long QT Syndrome, aiming to pioneer the first disease-modifying therapy for this rare disorder.
Vinay Prasad returns to top FDA post amid political whiplash and gene therapy fallout
Dr. Vinay Prasad has been reinstated as Chief Medical and Scientific Officer at the U.S. FDA just weeks after stepping down. His reappointment is reshaping biotech regulatory dynamics and reviving questions about scientific independence under political pressure.