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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...

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Human Drugs

Additional Ozempic Indication Approved

FDA approves a new indication for Novo Nordisks Ozempic to reduce the risk of worsening kidney disease and cardiovascular death in adults with Type 2 ...

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Medical Devices

Alzheimers Assay Gets Breakthrough Designation

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

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Human Drugs

Enhertu Approval Broadens Breast Cancer Use

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