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Breakthrough Status for Meniscus Knee Implant

[ Price : $8.95]

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

Orphan Drug Designation for Marsh Lymphoma Drug

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

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...

Additional Ozempic Indication Approved

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FDA approves a new indication for Novo Nordisks Ozempic to reduce the risk of worsening kidney disease and cardiovascular death in...

Alzheimers Assay Gets Breakthrough Designation

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FDA grants Beckman Coulter Diagnostics a breakthrough device designation for its Access p‑Tau217/β-Amyloid 1-42 plasma ...