FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
latest-news-card-1
Human Drugs

Cytokinetics Reports Exercise Data on Heart Drug

Cytokinetics reports topline results from its Phase 3 MAPLE-HCM clinical trial showing that aficamten significantly improved exercise capacity in pati...

latest-news-card-1
Human Drugs

Hunter Syndrome Gene Therapy Accepted for Review

FDA accepts for priority review a Regenxbio BLA seeking accelerated approval for gene therapy RGX-121 (clemidsogene lanparvovec) for treating Hunter s...

latest-news-card-1
Human Drugs

CGMP Violations at Chinas Shantou S.E.Z. Baojie

FDA warns Chinas Shantou S.E.Z. Baojie Industry about CGMP violations in its production of finished drugs, some of which may be regulated as cosmetics...

latest-news-card-1
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...

latest-news-card-1
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...

latest-news-card-1
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 ...

latest-news-card-1
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...

Animal Drugs

Taizhou Jingshang Cosmetics CGMP Issues

FDA warns Chinas Taizhou Jingshang Cosmetics Technology Co. about CGMP violations in its production of finished drugs.

latest-news-card-1
Marketing

FDA Hits Mayne Nextstellis Professional Presentation

The CDER Office of Prescription Drug Promotion hits Mayne Pharma over a professional presentation on Nextstellis that it says makes false and misleadi...