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

Gastrointestinal tolerability remained the dominant adverse-reaction cluster, aligning with established GLP‑1 receptor agonist class effects across dose ranges. A higher-dose signal of altered skin ...

While many in the biotechnology sector expressed excitement for faster drug approval timelines, some researchers voiced concerns that critical data review could be missed.

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

An FDA complete response letter for idebenone in LHON indicates unresolved NDA deficiencies and necessitates additional data before approval can be reconsidered. Priority review status and a February ...

FDA chief's office said it wants to cut the filing review from 60 days to one week The office said it may cut those reviews to two or three weeks based on complexity The agency could decide on Lilly's ...