FDA Related News

Human Drugs

FDA Doubts May Move Trials Overseas: Report

Biotech executives, investors, and consultants say some companies are moving early clinical trials overseas due to fears of instability and slowness a...

Human Drugs

FDA OKs First Oral Therapy for Rare Adrenal Tumors

FDA approves a Merck NDA for Welireg (belzutifan), an oral drug for treating adults and pediatric patients aged 12 and older with locally advanced, un...

Human Drugs

AbbVies Emrelis Approved for Lung Cancer

FDA gives AbbVie accelerated approval for its Emrelis (telisotuzumab vedotin-tllv) for treating certain adult patients with locally advanced or metast...

Medical Devices

BrightHeart AI Fetal Heart Ultrasound Checker Cleared

FDA clears a BrightHeart 510(k) for the B-Right Views, an artificial intelligence-powered tool that automatically detects the standard views required ...

FDA General

GAO Pushes Its FDA Recommendations to Kennedy

The Government Accountability Office tells HHS secretary Robert F. Kennedy, Jr., about priority recommendations it has made in the past to improve FDA...

Human Drugs

Indian API Maker Hit with Warning Letter

FDA sends Indian active pharmaceutical ingredient manufacturer Mentha & Allied Products a Warning Letter that cites the firm for significant GMP viola...

FDA Wants Public Deregulation Input

FDA and HHS ask public stakeholders for their ideas on regulations that should be eliminated.

Human Drugs

CGMP Violations at Excelvision Fareva

FDA warns Frances Excelvision Fareva about CGMP violations in its production of finished drugs.

Human Drugs

FDA Moves to Ban Pediatric Ingestible Fluoride Drugs

FDA plans to remove from the market concentrated ingestible fluoride prescription drug products for children, citing safety concerns and a lack of for...

Human Drugs

Assertio Pays $3.6 Million Over Improper Marketing

Assertio Therapeutics agrees to pay $3.6 million to resolve claims that it violated the False Claims Act by causing the submission of false claims abo...