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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

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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

[ 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...

Thermosome Gets Orphan Status on Sarcoma Drug

[ Price : $8.95]

FDA grants Thermosome an orphan drug designation for THE001 and its use in treating soft tissue sarcomas.

Zepbound Beats Wegovy in Trial: Lilly

[ Price : $8.95]

Eli Lillys Zepbound (tirzepatide) demonstrates significantly greater weight loss than Novo Nordisks Wegovy (semaglutide) in a head...

FDA Pulled Into Drug Pricing Fray

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A new Trump administration executive order on drug pricing is moving FDA into pricing aspects to help lower drug costs by offering...

United Imaging X-ray System Cleared

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FDA clears a United Imaging 510(k) for its first interventional X-ray system uAngio Aviva.

Oncology Office Launches Project Interface

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FDAs Oncology Center of Excellence launches Project Interface, a new initiative aimed at deepening engagement with cancer patients...