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FDA Cites Sanofi Over Misleading Beyfortus Promotional Emails

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FDA sends an untitled letter to Sanofi Vaccines U.S., alleging that promotional emails for its respiratory syncytial virus prevent...

Novo Nordisk Sues Lilly Over GLP-1 Ads

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Novo Nordisk sues Lilly in New Jersey federal court over what the company says is a misleading national ad campaign that compares ...

CGMP Issues at Indias Shimoga Chemicals

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FDA warns Indias Shimoga Chemicals about CGMP deviations in its production of active pharmaceutical ingredients.

No Informed Consent in Alembic Trial

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FDA warns Indias Alembic Research Center that it failed to obtain informed consent for an in vivo bioequivalence study.

Acadia Gets Fast Track for Alzheimers Psychosis Drug

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FDA awards Acadia Pharmaceuticals a Fast Track designation for remlifanserin, an investigational, highly selective, 5-HT2A recepto...

Make Better Use of 505(b)(2) Pathway: Column

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Two InnoDev Partners consultants urge industry to re-embrace the 505(b)(2) approval pathway in instances in which it can save drug...

China Surpasses U.S. in Novel Cancer Drug Approvals Since 2023: Analysis

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China approves more novel oncology drugs than the U.S. between 2020 and 2025, with its annual approval totals surpassing FDAs begi...

Dyne Therapeutics BLA for Duchenne Muscular Dystrophy

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FDA accepts for priority review a Dyne Therapeutics BLA for zeleciment rostudirsen for treating individuals with Duchenne muscular...

Nevada Man Pleads Guilty to Importing and Selling Misbranded Drugs

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A Nevada businessman enters guilty plea to importing and distributing misbranded prescription erectile dysfunction drugs from Indi...

Study Finds Compounded GLP-1 Market Remains Strong Despite FDA Crackdown

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A new study published in JAMA Health Forum suggests the market for compounded GLP-1 weight-loss drugs remains robust despite the F...