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Novo Nordisk Files CagriSema NDA for Weight Loss

[ Price : $8.95]

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

FDA Sends Warning Letters to Makers of Breast Binders

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FDA begins enforcement actions against companies illegally marketing breast binders to children, placing the agencys role at the c...

PDUFA Talks Hit Snag on Review Timelines/Transparency

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During recent drug user fee negotiations on reauthorizing the PDUFA program, FDA officials and pharmaceutical industry representat...

FDA OKs Subcutaneous Version of J&J Lung Cancer Drug

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

Clinical Hold on Lung Cancer Trial After Deaths

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

Congressional Dems Want Drug Deal Information

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

FDA Warns Catalent Indiana for CGMP Lapses

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

Change Premarin Prescribing Info to Include Equilin: Petition

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Diamond Research Foundation founder Beth Rosenshein petitions FDA to update Premarin labeling with information on the estrogen hor...

FDA Agentic AI Deployment Raises Concerns

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

GSK Long-Acting Biologic Approved for Asthma

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