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 ...
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 ...
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.
PharmTech

New Wegovy Dose Approved Under FDA’s CNPV

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

Legal questions swirl around FDA's new expedited drug program, including who should sign off

WASHINGTON (AP) — The Food and Drug Administration commissioner's effort to drastically shorten the review of drugs favored by President Donald Trump's administration is causing alarm across the ...
Becker's Hospital Review

FDA delays approval for anaphylaxis drug

The FDA has delayed approval of Aquestive Therapeutics’ new drug application seeking approval of Anaphylm, a sublingual epinephrine film for the treatment of Type 1 allergic reactions, including ...
Hosted on MSN

TVTX stock falls as FDA extends review timeline for Filspari sNDA

Shares of Travere Therapeutics TVTX were down 14.6% on Tuesday after the company announced that the FDA had extended the review timeline for the supplemental new drug application (sNDA) seeking label ...