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Stroke Device Cleared for Larger Catheters

[ Price : $8.95]

FDA clears an Imperative Care 510(k) for its Zoom System, a stroke thrombectomy system with .088-inch catheters.

Supernus Wins Label Update for ADHD Drug

[ Price : $8.95]

FDA approves a Supernus Pharmaceuticals label update for attention-deficit/hyperactivity disorder drug Qelbree (viloxazine extende...

Fast Track for Prostate Cancer Imaging Drug

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FDA grants Clarity Pharmaceuticals a fast track designation for 64Cu-SAR-bisPSMA for positron emission tomography imaging prostate...

Caranx Medical PMA for TAVIpilot AI Software

[ Price : $8.95]

Caranx Medical files a PMA for its TAVIpilot AI Software for real-time intra-operative guidance of transcatheter heart valve impla...

ALX Oncology Seeking Accelerated OK for Evorpacept

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ALX Oncology plans to discuss with FDA its path for seeking accelerated approval for CD47-blocker evorpacept based on positive upd...

FDA Approves Medexus Leukemia NDA

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FDA approves a Medexus NDA for Grafapex (treosulfan) for use with fludarabine as a preparative regimen for allogeneic hematopoiet...

FDA Delays Non-Rx Drug Final Rule

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Responding to a Trump Administration order, FDA delays the effective date until 3/21 of a recent final rule entitled Nonprescripti...

CDRHs Sara Brenner Elevated to Acting Commissioner

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HHS elevates CDRH chief medical officer for in vitro diagnostics Sara Brenner to FDA acting commissioner under the Trump Administr...

Keytruda+Lenvima Mixed Data in Gastroesophageal Cancer

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Merck and Eisai say results from the Phase 3 LEAP-015 trial evaluating Keytruda plus Lenvima in gastroesophageal adenocarcinoma pa...

FDA Will Review Biogen Spinraza sNDA

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FDA will review a Biogen sNDA for a Spinraza higher dose regimen.