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FDA/Aetion Oncology RWD Research

[ Price : $8.95]

The FDA Oncology Center of Excellence and Aetion open a five-year collaboration to research oncology real-world evidence sources.

GenBioPro Sues to Overturn WV Abortion Pill Law

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The manufacturer of the abortion pill mifepristone sues West Virginia over the states law that effectively bans using the drug for...

Merck Ending Keytruda Phase 3 Prostate Cancer Trial

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Merck terminates a Phase 3 trial of its Keytruda with other drugs as a treatment for some prostate cancers after an interim data r...

Panel Votes to Approve Cidaras Rezafungin

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An FDA advisory committee votes 14 to 1 to recommend that a Cidara Therapeutics NDA for rezafungin demonstrated a favorable benefi...

FDA Emails Show Pressure Vaccine Officials Were Under

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Emails released by FDA provide a glimpse of a frustrated senior FDA vaccine official arguing why her office could not compress its...

Pharmacists Group Pressuring FDA on Supply Chain Security

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The American Pharmacists Association urges pharmacies to join them in calling for FDA to postpone the upcoming Drug Supply Chain S...

7 Deadly Sins at FDA Presentations: Mikkael Sekeres

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Former FDA Oncologic Drugs Advisory Committee chairman Mikkael Sekeres looks at seven ways in which sponsor committee presentation...

Biogens Lou Gehrigs NDA Heads to Panel Review

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FDA announces a 3/22 Peripheral and Central Nervous System Drugs Advisory Committee to review Biogens tofersen, an investigational...

Verrica Pharma Re-Files Skin Disease Drug

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Verrica Pharmaceuticals resubmits an NDA resubmission for VP-102 to treat molluscum contagiosum, described by the Centers for Dise...

AdvaMed Device Sterilization Reg Proposals for EPA

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AdvaMed gives the Biden Administration three points to consider as it works with EPA to finalize an updated standard for ethylene ...