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FDA Early Alert Over Boston Scientific Transcarotid Catheter Systems

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FDA issues an early alert warning about a potentially high-risk issue involving certain lots of Boston Scientific's ENROUTE Transc...

FDA cites Bausch + Lomb Manufacturing Facility

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FDA cites Bausch + Lomb for GMP deficiencies following a 3/12-20 inspection of the company's sterile drug manufacturing facility i...

FDA: PDUFA 7 CMC Commitments Complete

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FDA publishes a strategy document on facilitating chemistry, manufacturing, and controls readiness for products in accelerated dev...

Efforts Needed to Improve Health Outcomes, Califf Says

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Former FDA commissioner Rob Califf tells a cardiology technology convention that the U.S. needs to make significant changes to imp...

HELP Committee Advances Biosimilar Bill

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The Senate HELP Committee advances legislation sponsored by Sen. Rand Paul that he says will speed approval of biosimilar drugs by...

FDA Cites SGS France Life Sciences Over Bioanalytical Method Validation

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A just-posted Form FDA 483 cites SGS France Life Sciences following an 8/2025 inspection, identifying multiple deficiencies involv...

J&J Reports Positive Data From Multiple Myeloma Study

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Johnson & Johnson reports promising topline results from the three-arm investigational Phase 3 MonumenTAL-6 study evaluating Tecva...

Lillys Retatrutide Hits Endpoint in 2 Trials

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Lilly says its triple hormone receptor agonist retatrutide met the primary weight loss endpoint in two Phase 3 trials.

FDA Should Ban DTC Drug Ads: Public Citizen

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Advocacy group Public Citizen files a petition urging FDA to ban prescription drug direct-to-consumer advertising.

FDA Accepts Revolution Medicines' NDA for Pancreatic Cancer Therapy

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FDA accepts for review Revolution Medicines' NDA for daraxonrasib, an investigational oral RAS-targeted therapy for patients with ...