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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

[ Price : $8.95]

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

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...

Revoke All mRNA Covid Vaccine BLAs: CHD Petition

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Childrens Health Defense asks FDA to revoke BLA approvals for all Pfizer and Moderna mRNA Covid-19 vaccines, claiming they do not ...

HCT/P Violations at Ponya Therapeutics

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FDA warns Brookhaven, GA-based Ponya Therapeutics about violations of regulations governing human cells, tissues, and cellular and...

FDA Clears Rx Digital Therapeutic for Adult ADHD

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FDA clears a Lumos Labs 510(k) for LumosityRx, a prescription digital therapeutic intended to improve attention in adults with att...

Positive Results for Roche Giredestrant in Some Breast Cancers

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Roche reports positive Phase 3 lidERA trial results for its giredestrant selective estrogen receptor degrader endocrine therapy in...