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FDA OKs 1st At-Home Stimulator for Depression

[ Price : $8.95]

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

Medical Device Recall Improvement Act Reintroduced

[ Price : $8.95]

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...

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...

FDA Neurological Regulator Joins Musks Neuralink

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Reuters reports that Daniel McMullen, the former director of the CDRH Office of Neurological and Physical Medicine Devices, has jo...

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 ...