FDA Related News

Human Drugs

Novo Nordisk Files CagriSema NDA for Weight Loss

Novo Nordisk says it expects FDA to review in 2026 the companys NDA for CagriSema, an injectable once-weekly weight loss treatment combining Ozempic w...

Medical Devices

FDA Sends Warning Letters to Makers of Breast Binders

FDA begins enforcement actions against companies illegally marketing breast binders to children, placing the agencys role at the center of a broader f...

Human Drugs

PDUFA Talks Hit Snag on Review Timelines/Transparency

During recent drug user fee negotiations on reauthorizing the PDUFA program, FDA officials and pharmaceutical industry representatives debate how far ...

Human Drugs

FDA OKs Subcutaneous Version of J&J Lung Cancer Drug

FDA approves a new subcutaneous formulation of Johnson & Johnsons lung cancer drug amivantamab, allowing the therapy to be administered in minutes rat...

Human Drugs

Clinical Hold on Lung Cancer Trial After Deaths

Regulators place a clinical hold on a pivotal lung cancer trial of ifinatamab deruxtecan after reports of treatment-related deaths from lung toxicity,...

Human Drugs

Congressional Dems Want Drug Deal Information

House and Senate Democratic health leaders ask AstraZeneca, Lilly, Novo Nordisk, and Pfizer for details about the drug pricing deals the companies mad...

Human Drugs

FDA Warns Catalent Indiana for CGMP Lapses

FDA issues a Warning Letter to Catalents Bloomington, IN, drug manufacturing plant, citing significant manufacturing violations after investigators fo...

Human Drugs

Change Premarin Prescribing Info to Include Equilin: Petition

Diamond Research Foundation founder Beth Rosenshein petitions FDA to update Premarin labeling with information on the estrogen hormone equilin that is...

FDA Agentic AI Deployment Raises Concerns

Two Mintz attorneys urge stakeholders to monitor FDA communications involving compliance and review carefully, looking for issues with information tha...

Human Drugs

GSK Long-Acting Biologic Approved for Asthma

FDA approves GSKs Exdensur (depemokimab-ulaa), an ultra-long-acting biologic for severe asthma.