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Restrict 2 Opioid Indications: Petition

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Physician Douglas Smith petitions FDA to take 11 steps to curtail the use of the indications of opioid addiction and opioid use di...

ZyVersa Touts Approval Path for Kidney Disorder Drug

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ZyVersa Therapeutics says a new regulatory development could significantly shorten the path to approval for treatments targeting f...

FDA Like Flat Earthers Taking Over NASA: Woodcock

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Three former FDAers warn of a slow-moving catastrophe coming for the agency as it loses staff and resources under leaders who have...

FDA OKs Opdivo/Yervoy in Colon Cancer

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FDA approves Bristol Myers Squibbs combination of Opdivo (nivolumab) with Yervoy (ipilimumab) for treating certain adult and pedia...

Multiple Violations at EpiCare Acquisitions

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FDA warns Lawrenceville, NJ-based EpiCare Acquisitions about Quality System and other violations in its manufacturing of a family ...

Bausch Recalls Intraocular Lenses After Reports

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Bausch + Lomb recalls its enVista intraocular lenses after the company received reports of complications, which it says could not ...

Laboratory-Developed Test Decision Reviewed

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Six Sidley attorneys raise several practical questions arising from a Texas federal court decision finding that FDA does not have ...

Rhythm Pharma Positive Data on Obesity Drug

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Rhythm Pharmaceuticals announces positive topline results from the pivotal Phase 3 TRANSCEND trial evaluating setmelanotide for tr...

Teva Files sBLA to Expand Migraine Therapys Use

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FDA accepts for review a Teva Pharmaceuticals supplemental BLA for Ajovy (fremanezumab-vfrm) to expand the indication to include p...

Device Reviews Will Now Take Longer: Shuren

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Former CDRH director Jeff Shuren says recent staff cuts at CDRH will likely lead to longer review times.