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Human Drugs

FDA Approves Axsomes Migraine Drug

FDA approves Axsome Therapeutics Symbravo (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults.

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Human Drugs

FDA Clears Roche Lipoprotein (a) Assay

FDA clears a Roche 510(k) for its Tina-quant Lipoprotein (a) Gen.2 Molarity assay that measures lipoprotein (a) in nanomoles per liter.

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Medical Devices

Breakthrough Status for Meniscus Knee Implant

FDA grants OrthoPreserve a breakthrough device designation for its Defender meniscus replacement knee implant.

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Human Drugs

Orphan Drug Designation for Marsh Lymphoma Drug

FDA grants orphan drug designation to March Biosciences MB-105 to treat relapsed/refractory CD5-positive T-cell lymphoma.

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Human Drugs

Adial Finishes Alcohol Abuse Drug PK Study

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

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FDA General

Trust in Health Agencies Continues Decline: KFF

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

Biologics

Better Vaccine Communication Needed: Column

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

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Human Drugs

FDA Modernization Act 3.0 Reintroduced

Sen. Cory Booker and eight others in a bipartisan coalition reintroduce legislation to force FDA to implement the FDA Modernization Act that Congress ...

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FDA General

RFK Jr. Grilled by Dems at Confirmation Hearing

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

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Biologics

FDA Accepts BLA for Alvotechs Simponi BLA

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