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Human Drugs

Edwards Lifesciences Recalls Optisite Arterial Cannula

Edwards Lifesciences recalls its Optisite Arterial Cannula due to complaints received about its 3mm to 4mm section wire exposed/protruding from the ou...

Biologics

FDA Conducting Benefit-Risk Modeling on Covid Vaccines

FDA leaders say that the agency is currently conducting benefit-risk modeling studies based on the evolving risk of Covid-19 severe outcomes and the l...

Human Drugs

Merck Winrevair sBLA Seeks Updated Label on Risk Reduction

FDA accepts for priority review a Merck supplemental BLA for Winrevair (sotatercept-csrk), seeking to update its label to reflect new data showing a s...

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Human Drugs

FDA Rejects Capricor Duchenne Cell Therapy

FDA issues Capricor Therapeutics a complete response on its BLA for Deramiocel, a cell therapy candidate targeting cardiomyopathy associated with Duch...

Human Drugs

Intuitive Vessel Sealer Cleared for da Vinci Devices

FDA clears an Intuitive 510(k) for its Vessel Sealer Curved advanced energy instrumentation for use with its multiport da Vinci systems.

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Biologics

Interchangeable Biosimilar Product Development Workshop

FDA announces a 9/19 scientific workshop to discuss the development of interchangeable biosimilar products to help identify future needs (e.g., guidan...

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Human Drugs

Complete Response Letters to be Posted in Real Time: FDA

FDA commissioner Marty Makary pledges to release new complete response letters in real time.

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Medical Devices

Breakthrough Status for AI Prostate Treatment Planner

FDA grants Artera a breakthrough device designation for its ArteraAI Prostate, an artificial intelligence-based tool to help treat patients with local...

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Human Drugs

Milestone Pharma Resubmits Cardamyst NDA

FDA accepts for review a Milestone Pharmaceuticals NDA resubmission for Cardamyst (etripamil) nasal spray, a self-administered treatment for paroxysma...

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Human Drugs

Access to Care House Hearing Set

The House Energy and Commerce Health Subcommittee schedules a 7/16 hearing on preserving access to timely and affordable care.