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BrightHeart AI Fetal Heart Ultrasound Checker Cleared

[ Price : $8.95]

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

GAO Pushes Its FDA Recommendations to Kennedy

[ Price : $8.95]

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

Indian API Maker Hit with Warning Letter

[ Price : $8.95]

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

FDA Wants Public Deregulation Input

[ Price : $8.95]

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

CGMP Violations at Excelvision Fareva

[ Price : $8.95]

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

FDA Moves to Ban Pediatric Ingestible Fluoride Drugs

[ Price : $8.95]

FDA plans to remove from the market concentrated ingestible fluoride prescription drug products for children, citing safety concer...

Assertio Pays $3.6 Million Over Improper Marketing

[ Price : $8.95]

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

Taizhou Jingshang Cosmetics CGMP Issues

[ Price : $8.95]

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

FDA Hits Mayne Nextstellis Professional Presentation

[ Price : $8.95]

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

GSK, iTeos Therapeutics Scrap Lung Cancer Candidate

[ Price : $8.95]

GSK and iTeos Therapeutics decide to stop the development of belrestotug, an anti-TIGIT monoclonal antibody for treating certain n...