FDA Related News

Novo Nordisk Sues Lilly Over GLP-1 Ads

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

Human Drugs

CGMP Issues at Indias Shimoga Chemicals

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

Human Drugs

No Informed Consent in Alembic Trial

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

Human Drugs

Acadia Gets Fast Track for Alzheimers Psychosis Drug

FDA awards Acadia Pharmaceuticals a Fast Track designation for remlifanserin, an investigational, highly selective, 5-HT2A receptor inverse agonist fo...

Human Drugs

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

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

Human Drugs

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

China approves more novel oncology drugs than the U.S. between 2020 and 2025, with its annual approval totals surpassing FDAs beginning in 2023, accor...

Biologics

Dyne Therapeutics BLA for Duchenne Muscular Dystrophy

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

Human Drugs

Nevada Man Pleads Guilty to Importing and Selling Misbranded Drugs

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

Human Drugs

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

A new study published in JAMA Health Forum suggests the market for compounded GLP-1 weight-loss drugs remains robust despite the FDA's resumption of e...

FDA General

FDA, DoJ Expanding Enforcement Across Healthcare Ecosystem, Attorney Says

In a mid-year enforcement update, Arnold Golden Gregory partner Gabriel Scannapieco says FDA and the Department of Justice are increasingly extending ...