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FDA Orders Crackdown on Misleading Prescription Drug Ads

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In a new crackdown on drug advertising, FDA orders pharmaceutical companies to remove any noncompliant ads and bring all promotion...

FDA Digital Health Leader Leaves for Mayo Clinic

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Former FDA Digital Health Center of Excellence acting director Sonja Fulmer leaves the agency to accept a position at Mayo Clinic ...

Expanded Approval for AZs Koselugo

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FDA approves an expanded indication to include pediatric patients aged one and older for AstraZenecas Koselugo to treat some cases...

CGMP API Deviations at Hikal Limited

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FDA warns Jigani, Karnataka, India-based Hikal Limited about CGMP deviations in its production of active pharmaceutical ingredient...

Issues in 3 Trials Conducted by Detroit Doctor

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FDA warns Detroit, MI-based medical oncologist Shirish Gadgeel about bioresearch monitoring violations in his conduct of three cli...

Former CBER Therapeutics Deputy Anatol Joins Lilly

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Eli Lilly hires former CBER Office of Therapeutic Products (OTP) deputy director Rachael Anatol, who was removed from her agency p...

Lexicon Submits New Data on Stalled Diabetes Drug

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Lexicon Pharmaceuticals submits new clinical data to FDA that attempts to advance its stalled NDA for its diabetes drug Zynquist (...

Capricor Posts Bytreldo CRL Response

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Capricor Therapeutics posts its response to an FDA complete response letter for Bytreldo since the agency published the letter pub...

NRx Petitions FDA to Ban Preservative in Ketamine

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NRx Pharmaceuticals petitions FDA seeking a ban on all ketamine products formulated with the preservative benzethonium chloride, a...

7th Circuit Backs Dismissal of AbbVie False Claims Suit

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The 7th Circuit Court of Appeals affirms, although for different legal reasons, a federal district court ruling rejecting a False ...