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Lilly Sues FDA Over Retatrutide Designation

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Lilly asks an Indiana federal court to overturn an FDA determination that the companys retatrutide is a drug rather than a biologi...

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...

More Support for Treating All Biologics the Same

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Two drug trade associations support an FDA approach to postapproval manufacturing changes in biosimilar and interchangeable biosim...

FDA OKs AZs Tagrisso Lung Cancer Drug

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FDA approves AstraZenecas Tagrisso for some non-small cell lung cancers.