FDA to offer bonus payments to staffers who complete speedy drug reviews
WASHINGTON (AP) — The head of the Food and Drug Administration plans to start offering bonus payments to…
FDA will drop two-study requirement for new drug approvals, aiming to speed access
WASHINGTON (AP) — The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous…
FDA will drop two-study requirement for new drug approvals, aiming to speed access
WASHINGTON (AP) — The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous…
FDA accepts BMS protein degrader for review; Disc rare disease drug rejected
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free…
Doctors Warn: Common Daily Supplement Mistake Could Harm Your Health
About 75% of Americans take some kind of supplement regularly, making it a common practice in the U.S.…
Disc Medicine to pursue traditional U.S. approval after FDA rejects new fast-track route
Feb 17 (Reuters) – Disc Medicine said ‌on Tuesday it ‌will pursue a traditional ​U.S. approval pathway for…
Nektar, continuing comeback, says eczema drug’s effects hold up in follow-up study
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free…
Over-the-counter ivermectin sales proposed in Georgia
ATLANTA, Ga. (Atlanta News First) — A Georgia state lawmaker wants to allow over-the-counter sales of a drug…
Vanda Pharmaceuticals Announces Receipt of FDA Decision Letter on HETLIOZ® Supplemental New Drug Application for Jet Lag Disorder
WASHINGTON, Jan. 8, 2026 /PRNewswire/ — Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that it has received…
BioXcel Therapeutics Planning to Submit sNDA This Month Seeking FDA Approval for At-Home Use of IGALMI®
BioXcel Therapeutics Company remains focused on potential approval and launch of IGALMI® for the acute treatment of agitation…
US FDA declines to approve Corcept’s drug for rare hormonal disorder
By Sneha S K and Sahil Pandey Dec 31 (Reuters) – The U.S. Food and Drug Administration has…
Vanda Jumps 21% After FDA Approves Motion Sickness Therapy
This article first appeared on GuruFocus. Vanda Pharmaceuticals (NASDAQ:VNDA) jumped roughly 21% in premarket trading after the U.S.…