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Eugia Pharma Specialties FDA-483 Out

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

Keep GLP-1s Off Bulks List: FDA

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

Nubeqa TV Ad, Video Misleading: FDA

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

Using AI in Drug Development

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

House Committee Advances FDA Funding Bill Amid Policy Disputes

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

1st Non-Antipsychotic OKd for Agitation in Alzheimers Patients

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

FDA Panel Rejects Astrazenecas Camizestrant In Closely Watched Vote

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

Enrollment Halted in Newrons Schizophrenia Study After Patient Death

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

Prospective AI Versioning Standard Needed: Post

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A Clinical Trial Vanguard online post makes the case for further FDA guidance so drug trial sponsors can successfully incorporate ...

Purdue Sentencing Sets $5.3 Billion in Criminal Penalties

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A federal court sentences Purdue Pharma to pay more than $5 billion in criminal penalties for its role in the U.S. opioid epidemic...