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Atara Refiles BLA for Gene Therapy

[ Price : $8.95]

Atara Biotherapeutics resubmits its BLA for Ebvallo (tabelecleucel or tab-cel), seeking approval for its use as monotherapy for tr...

FDA Mum on Hiring Freeze and Staff RIFs

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FDA faces new uncertainty over its staffing and regulatory capacity following sweeping federal hiring restrictions and a pivotal S...

Bayer sNDA for Kerendia Expanded Use Approved

[ Price : $8.95]

FDA approves a Bayer supplemental NDA to expand the labeling of Kerendia (finerenone) for reducing the risk of cardiovascular deat...

Edwards Lifesciences Recalls Optisite Arterial Cannula

[ Price : $8.95]

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

FDA Conducting Benefit-Risk Modeling on Covid Vaccines

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

Merck Winrevair sBLA Seeks Updated Label on Risk Reduction

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

FDA Rejects Capricor Duchenne Cell Therapy

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

Intuitive Vessel Sealer Cleared for da Vinci Devices

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

Interchangeable Biosimilar Product Development Workshop

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FDA announces a 9/19 scientific workshop to discuss the development of interchangeable biosimilar products to help identify future...

Complete Response Letters to be Posted in Real Time: FDA

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