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Human Drugs

Pfizer Pays $60 million to Settle Biohaven Kickbacks

Pfizer agrees to pay $59.7 million to resolve allegations that its subsidiary, Biohaven Pharmaceutical, engaged in previous illegal kickback schemes.

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Human Drugs

Vanda Files NDA for Motion Sickness Drug

Vanda Pharmaceuticals files an NDA for tradipitant for treating motion sickness.

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Medical Devices

ClearPoint Neuro Cleared for CT-Guided Procedures

FDA clears a ClearPoint Neuro 510(k) for its ClearPoint Navigation Software Version 3.0, which the company says introduces an intraoperative computed ...

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Human Drugs

Fast Track for Prostate Cancer Imaging Drug

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

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Human Drugs

Caranx Medical PMA for TAVIpilot AI Software

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

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Human Drugs

ALX Oncology Seeking Accelerated OK for Evorpacept

ALX Oncology plans to discuss with FDA its path for seeking accelerated approval for CD47-blocker evorpacept based on positive updated data from the A...

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Human Drugs

FDA Approves Medexus Leukemia NDA

FDA approves a Medexus NDA for Grafapex (treosulfan) for use with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transpl...

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Human Drugs

FDA Delays Non-Rx Drug Final Rule

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

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Human Drugs

CDRHs Sara Brenner Elevated to Acting Commissioner

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

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Human Drugs

Keytruda+Lenvima Mixed Data in Gastroesophageal Cancer

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