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Human Drugs

Expanded Access Program for Promising Pancreatic Cancer Drug

FDA authorizes an expanded access program for an experimental pancreatic cancer therapy from Revolution Medicines, allowing certain patients to receiv...

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Human Drugs

Veppanu Approved for Advanced Breast Cancer

FDA has approved Arvinas Operations Veppanu (vepdegestrant) for treating certain patients with advanced breast cancer, marking the first authorization...

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Human Drugs

Eugia Pharma Specialties FDA-483 Out

FDA releases the form FDA-483 with three observations from an inspection at Indias Eugia Pharma Specialties Limited.

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Human Drugs

Keep GLP-1s Off Bulks List: FDA

FDA proposes not to include semaglutide, tirzepatide, and liraglutide on the 503 Bulks List of drugs that can be legally compounded from bulk substanc...

Marketing

Nubeqa TV Ad, Video Misleading: FDA

The CDER Office of Prescription Drug Promotion cautions Bayer that a video and TV ad for its Nubeqa omit important risk information and contain elemen...

Human Drugs

Using AI in Drug Development

Five Hogan Lovells attorneys discuss ways in which life sciences companies can use artificial intelligence in drug development and regulatory submissi...

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FDA General

House Committee Advances FDA Funding Bill Amid Policy Disputes

The U.S. House Appropriations Committee votes to approve a spending bill to fund FDA for fiscal year 2027.

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Human Drugs

1st Non-Antipsychotic OKd for Agitation in Alzheimers Patients

FDA approves an expanded use for Axsome Therapeuticss Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) to treat agitation associat...

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Human Drugs

FDA Panel Rejects Astrazenecas Camizestrant In Closely Watched Vote

An FDA advisory committee votes 6 to 3 against supporting AstraZenecas investigational breast cancer therapy camizestrant.

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Human Drugs

Enrollment Halted in Newrons Schizophrenia Study After Patient Death

Following a reported patient death, FDA places a hold on new patient enrollment at U.S. sites participating in ENIGMA-TRS 2 study, a late-stage trial ...