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Serina Files Response on Parkinsons Drug Clinical Hold

[ Price : $8.95]

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...

No FDAAA Difference in Time to 1st Postmarket Safety Action: Study

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Researchers say that the enhanced FDA regulatory authority from the 2017 FDA Amendments Act did not significantly change the time ...

WLF Warns on New DTC Ad Rules Violating First Amendment

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The Washington Legal Foundation cautions that the Trump administrations ongoing crackdown on direct-to-consumer pharmaceutical adv...

FDA OKs 1st Gene Therapy for Wiskott-Aldrich Syndrome

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FDA approves Italian non-profit Fondazione Telethons BLA for Waskyra (etuvetidigene autotemcel), the first gene therapy for Wiskot...