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Human Drugs

Lillys Triple-Agonist Cuts Weight by Nearly 29%

Eli Lillys investigational triple-agonist retatrutide shows substantial weight loss and meaningful reductions in knee osteoarthritis pain in a pivotal...

Medical Devices

Exceptional Performance of TAP Pilot: Report

An independent assessment of the FDA Total Product Lifecycle Advisory Program pilot finds it met its objectives exceptionally well and has several opp...

Medical Devices

Healthcare Opposition to Cybersecurity Reg Change

Cardiovascular Business reports that the American College of Cardiology has joined numerous other healthcare organizations in asking HHS to withdraw a...

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Medical Devices

FDA OKs 1st At-Home Stimulator for Depression

FDA approves the first at-home, prescription-only brain-stimulation device to treat major depressive disorder.

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Human Drugs

Serina Files Response on Parkinsons Drug Clinical Hold

Serina Therapeutics files a complete response to an FDA clinical hold on SER-252, the companys lead investigational therapy for advanced Parkinsons di...

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Medical Devices

Medical Device Recall Improvement Act Reintroduced

Rep. Jan Schakowsky and Sen. Dick Durbin reintroduce their Medical Device Recall Improvement Act to improve medical device recall communications betwe...

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FDA General

FDA Signals Plan to Ease Supplement-Label Disclaimers

FDA weighs changes to a long-standing labeling rule for dietary supplements and will temporarily exercise enforcement discretion on certain disclaimer...

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Biologics

OpdivoAVD Priority Review for Hodgkin Lymphoma

FDA accepts for priority review a Bristol Myers Squibb supplemental BLA for Opdivo (nivolumab) and its use in combination with AVD chemotherapy for ad...

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Human Drugs

2 Observations on Astellas Pharma FDA-483

FDA releases the form FDA-483 with two observations from an inspection at the Astellas Pharma sterile drug manufacturing facility in Takaoka, Toyama, ...

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Human Drugs

DoJ urges High Court Review of Skinny-Label Dispute

The U.S. government urges the Supreme Court to take up a patent-infringement dispute to decide whether generic drugmakers may face liability for induc...