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FDA OKs First Oral Therapy for Rare Adrenal Tumors

[ Price : $8.95]

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

AbbVies Emrelis Approved for Lung Cancer

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

BrightHeart AI Fetal Heart Ultrasound Checker Cleared

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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

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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

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

FDA Wants Public Deregulation Input

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

CGMP Violations at Excelvision Fareva

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

FDA Moves to Ban Pediatric Ingestible Fluoride Drugs

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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

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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

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