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Adial Finishes Alcohol Abuse Drug PK Study

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Adial Pharmaceuticals reports positive results from its pharmacokinetic study of ondansetron to treat alcohol use disorder

Trust in Health Agencies Continues Decline: KFF

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The latest Kaiser Family Foundation health information and trust tracking poll sees a continuing decline in public trust in FDA an...

Better Vaccine Communication Needed: Column

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A MedPageToday column calls for a whole new approach to communicating about vaccines to persuade people to use them.

FDA Modernization Act 3.0 Reintroduced

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Sen. Cory Booker and eight others in a bipartisan coalition reintroduce legislation to force FDA to implement the FDA Modernizatio...

RFK Jr. Grilled by Dems at Confirmation Hearing

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Robert F. Kennedy Jr. faces heated questioning during his confirmation hearing for his stances on vaccines, abortion rights, and c...

FDA Accepts BLA for Alvotechs Simponi BLA

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FDA accepts for review an Alvotech and Teva Pharmaceuticals BLA for AVT05, a proposed biosimilar to Janssen Biotechs Simponi and S...

Enhertu Approval Broadens Breast Cancer Use

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FDA approves AstraZeneca and Daiichi Sankyos Enhertu (trastuzumab deruxtecan) for treating adult patients with unresectable or met...

No Informed Consent at Trial Site: FDA

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FDA warns the Miami Dade Medical Research Institute and Dr. Americo Padilla about failing to obtain proper informed consent for pe...

2 Firms Illegally Selling Biologics: FDA

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FDA warns New York, NY-based Evolutionary Biologics and Chatsworth, CA-based Chara Biologics about illegally manufacturing and dis...

FDA Priority Review for New Merck Welireg Indication

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FDA sets 5/25 for its decision on a new indication for Mercks Welireg to treat patients with advanced pheochromocytoma and paragan...