Denali Therapeutics Announces U.S. FDA Approval of AVLAYAH™ (tividenofusp alfa-eknm) for ...

First new FDA-approved treatment option in nearly 20 years for families living with this rare lysosomal storage diseaseFirst FDA-approved ...
The Scientist

New FDA Policies for Faster Drug Reviews Met with Mixed Reactions

While many in the biotechnology sector expressed excitement for faster drug approval timelines, some researchers voiced ...
PharmTech

New Wegovy Dose Approved Under FDA’s CNPV

Gastrointestinal tolerability remained the dominant adverse-reaction cluster, aligning with established GLP‑1 receptor ...

US FDA approves higher dose of Novo's Wegovy under new fast-track review program

March 19 (Reuters) - Novo Nordisk said on Thursday the U.S. Food and Drug Administration has approved a higher dose of its ...
Blockonomi

Rocket Pharmaceuticals (RCKT) Stock Surges After FDA Approves Groundbreaking Gene Therapy

Rocket Pharmaceuticals (RCKT) stock surged 9% after FDA approved KRESLADI, the first gene therapy for severe LAD-I in ...
Ophthalmology Times

FDA issues complete response letter for idebenone in LHON

An FDA complete response letter for idebenone in LHON indicates unresolved NDA deficiencies and necessitates additional data ...
Opinion
Worcester Telegram on MSNOpinion

Opinion/Guest column: Fastest route to FDA approval not the best

The strength and credibility of the FDA relies on maintaining a clear line between evidence-based, scientific rigor and political priority setting.