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Order Wells Pharma Indomethacin Off Market: Petition

[ Price : $8.95]

A Wiley Rein petition filed for a client asks FDA to order the immediate withdrawal of Wells Pharmas compounded 100 mg indomethaci...

FDA Approves First Interchangeable Perjeta Biosimilar

[ Price : $8.95]

FDA approves Shanghai Henlius Biologics Poherdy (pertuzumab-dpzb), the first interchangeable biosimilar to Genentechs Perjeta (per...

Oversight of Influencer Social Media Posts Hard: Researchers

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University of Chicago researchers explain how difficult it will be to improve government oversight over social media influencer pr...

FDA Qualifies GLDH Biomarker

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FDA qualifies glutamate hydrogenase as a biomarker to enhance liver safety monitoring in clinical trials.

FDA Unveils Plausible Mechanism Approval Pathway

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FDA introduces a new regulatory framework the plausible mechanism pathway designed to speed approval of highly personalized ther...

OGD Four-Part Harmony MAPP

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The CDER Office of Generic Drugs publishes a MAPP to help assessors use the four-part harmony approach in OGD-related communicatio...

Alkermes Reports Phase 2 Results for Narcolepsy Drug

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Alkermes announces that its investigational once-daily therapy alixorexton significantly improved wakefulness and reduced daytime ...

MAHA Summit to Hear from Vance, Kennedy, Makary

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A MAHA Summit on 11/19 will hear from vice president JD Vance, HHS secretary Robert F. Kennedy, Jr., and FDA commissioner Marty Ma...

Petition Urges FDA to Ease Oversight of Stem Cell Products

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A biotechnology company specializing in adult-derived stem cells urges FDA to relax federal regulation of some regenerative therap...

FDA, USP, and Industry Convene to Boost Drug Quality

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FDA joins the United States Pharmacopeia and the Association for Accessible Medicines next month for a public workshop focused on ...