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Exceptional Performance of TAP Pilot: Report

[ Price : $8.95]

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

FDA OKs 1st At-Home Stimulator for Depression

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

Medical Device Recall Improvement Act Reintroduced

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

Serina Files Response on Parkinsons Drug Clinical Hold

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

FDA Signals Plan to Ease Supplement-Label Disclaimers

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

2 Observations on Astellas Pharma FDA-483

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

Lillys Triple-Agonist Cuts Weight by Nearly 29%

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Eli Lillys investigational triple-agonist retatrutide shows substantial weight loss and meaningful reductions in knee osteoarthrit...

Healthcare Opposition to Cybersecurity Reg Change

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Cardiovascular Business reports that the American College of Cardiology has joined numerous other healthcare organizations in aski...

OpdivoAVD Priority Review for Hodgkin Lymphoma

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

DoJ urges High Court Review of Skinny-Label Dispute

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