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Regulated Companies Fear FDA Cuts Impact

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Wired reports that several FDA-regulated companies have informed the Securities and Exchange Commission that their business could ...

Musks DOGE Cancels Leases on 30 FDA Field Offices

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Elon Musks Department of Government Efficiency (DOGE) terminates the leases of 30 FDA field offices and laboratories throughout th...

FDA Clears Damae Medicals deepLive Skin Imager

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FDA clears a Damae Medical 510(k) for its deepLive, an artificial intelligence-based imaging tool that provides real-time, three-d...

OPDP Hits Edenbridge Pharma Over Promos

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CDER's Office of Prescription Drug Promotion sends an untitled letter to Edenbridge Pharmaceuticals over Hemady promotional materi...

Corcept Files NDA for Cushings Syndrome Drug

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FDA accepts for review a Corcept Therapeutics NDA for relacorilant and its use in treating patients with endogenous hypercortisoli...

Rusfertide Phase 3 Data Meet Endpoints

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Protagonist Therapeutics and Takeda report positive topline results for the Phase 3 VERIFY study that is evaluating rusfertide for...

Lexicon Taps Pilavapadin 10mg for Phase 3

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Lexicon Pharmaceuticals says it will advance pain drug pilavapadin 10mg into a planned Phase 3 trial based on just-announced Phase...

PharmaTher Resubmits Ketamine NDA

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PharmaTher also said it was working with its third-party manufacturing partner to resolve the deficiencies.

Boston Scientific Recalls Pacemakers

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Boston Scientific recalls its Accolade pacemakers and Visionist and Valitude cardiac resynchronization therapy pacemakers due to t...

Philips Recalls Tack Endovascular Device

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Philips recalls its Tack Endovascular Systems due to customer complaints, including events where additional interventions were req...