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Conflict of Interest Seen in Kisunla Approval

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Investigative journalists write in BMJ about FDA advisory committee members financial conflicts of interest in the consideration o...

Bayer Files Nubeqa sNDA for Prostate Cancer

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Bayer submits a supplemental NDA for oral androgen receptor inhibitor Nubeqa (darolutamide), seeking approval for its use in combi...

ODAC Nixes Checkpoint Inhibitors in Gastric Cancers

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The FDA Oncology Drugs Advisory Committee votes not to recommend using immune checkpoint inhibitors in first-line advanced gastric...

Info Collection on Device Recall Authority

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Federal Register notice: FDA sends to OMB an information collection extension entitled Medical Device Recall Authority.

Merck Favezelimab/Keytruda Trial Misses Endpoint

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Merck says a trial assessing favezelimab and Keytruda (pembrolizumab) failed to meet its primary endpoint in patients with previou...

FDA Posts 2 FDA-483s

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FDA posts forms FDA-483 issued following inspections at Samsung Bioepis in Incheon, Republic of Korea, and Terumo Yamaguchi in Yam...

Democrat Lawmakers Seek Probe of Shuren Conflicts

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Two House Democrat lawmakers ask the HHS Office of Inspector General to investigate potential conflict-of-interest appearances rai...

FDA, CBP Seize Counterfeit Weight Loss Drugs

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Media reports indicate that FDA and Customs and Border Protection intercepted $270,000 worth of counterfeit and unapproved weight ...

Piur Device Converting 2D Scans to 3D Cleared

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FDA clears a Piur Imaging 510(k) for the Piur tUS Infinity that transforms existing 2D ultrasound devices into advanced 3D imaging...

Workshop on Live Biotherapeutics for Enterocolitis

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Federal Register notice: FDA, CDC, and NIH announce an 11/25 public workshop entitled Live Biotherapeutic Products to Prevent Necr...