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Human Drugs

Improving Myelodysplastic Syndromes Trials

Cancer researchers from FDA and academic medical centers report recommendations from a panel of experts convened to find ways to improve drug developm...

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Human Drugs

FDA Lifts Hold on Inhibikase Parkinsons Trial

FDA lifts its clinical hold on an Inhibikase trial of its IkT 148-009 in Parkinsons disease.

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Human Drugs

BsUFA Regulatory Research Roadmap

FDA issues a BsUFA 3 regulatory science research roadmap highlighting areas where pilot demonstration projects could improve science-based recommendat...

Human Drugs

FDA/Aetion Oncology RWD Research

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

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Human Drugs

GenBioPro Sues to Overturn WV Abortion Pill Law

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

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Human Drugs

Merck Ending Keytruda Phase 3 Prostate Cancer Trial

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

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Human Drugs

Panel Votes to Approve Cidaras Rezafungin

An FDA advisory committee votes 14 to 1 to recommend that a Cidara Therapeutics NDA for rezafungin demonstrated a favorable benefit-risk profile in tr...

Biologics

FDA Emails Show Pressure Vaccine Officials Were Under

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

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Human Drugs

Pharmacists Group Pressuring FDA on Supply Chain Security

The American Pharmacists Association urges pharmacies to join them in calling for FDA to postpone the upcoming Drug Supply Chain Security Act (DSCSA) ...

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Human Drugs

7 Deadly Sins at FDA Presentations: Mikkael Sekeres

Former FDA Oncologic Drugs Advisory Committee chairman Mikkael Sekeres looks at seven ways in which sponsor committee presentations can create problem...