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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.

Gileads Single-Tablet HIV Regimen Meets Trial Endpoint

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Gilead Sciences says its investigational single-tablet regimen combining bictegravir and lenacapavir met its primary endpoint in a...

Outlook Therapeutics BLA Resubmitted for Wet AMD

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FDA accepts for review an Outlook Therapeutics BLA resubmission for ONS-5010 (bevacizumab-vikg), an investigational ophthalmic for...

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 ...

What FDA Might Want in Chatbot Therapy for Depression

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Orrick attorneys say discussions at an FDA Digital Health Advisory Committee meeting indicate the agency intends to adopt oversigh...