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FDA Hits Alar Pharmaceuticals Experimental Ketamine Promotion

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FDA issues Alar Pharmaceuticals an untitled letter over promotional materials for its investigational ketamine drug, ALA-3000, bec...

Study Finds Drug Approvals Increasingly Rely on Fewer Trials

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FDAs approval of new drugs is increasingly being supported by fewer clinical studies.

Alert on Boston Scientifics Angiographic Catheters

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FDA issues an Early Alert after becoming aware that Boston Scientific sent a letter to customers recommending all Imager II Angiog...

FDA OKs Lilly's Mounjaro to Reduce CV Risk in Adults with Diabetes

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FDA approves Eli Lillys Mounjaro (tirzepatide) for lowering the risk of major adverse cardiovascular events.

FDA Approves Updated Covid-19 Vaccines for Upcoming Season

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FDA approves updated Covid-19 vaccines from Moderna, Pfizer-BioNTech and Novavax/Sanofi for the upcoming vaccination season.

First Oral Drug Indicated to Treat Dermatomyositis Approved

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The agency approves Priovant Therapeutics Lisraya (brepocitinib) tablets for treating dermatomyositis in adults.

FDA Promotion Crackdown Enters New Phase: Attorneys

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Attorneys from Arnall Golden Gregory examine and offer advice on FDAs intensified scrutiny of drug advertising, advising companies...

Senate Report Raises Questions About Oversight of Mifepristone Providers

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A new report from Senate HELP chair Bill Cassidy (R-LA) targets FDA for allowing the abortion drug mifepristones Risk Evaluation a...

Boebert Bill to Ease Botanical Drug Development

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Rep. Lauren Boebert introduces legislation to remove some barriers to the development of botanical drugs.

Support, Suggestions for Expedited IND Pilot

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Five stakeholders support an FDA proposal for an expedited IND pilot program and suggest ways to improve it.