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Valar Labs Wins Breakthrough Status for AI Bladder Cancer Test

[ Price : $8.95]

FDA grants Valar Labs a breakthrough device designation for its Vesta Bladder Risk Stratify Dx test.

FDA Approves Guardant Healths Next-Generation Guardant360 Liquid CDx

[ Price : $8.95]

FDA approves Guardant Healths next-generation Guardant360 Liquid CDx, a blood-based comprehensive genomic profiling test designed ...

ImmunityBios Anktiva sBLA for Expanded Use Accepted by FDA

[ Price : $8.95]

FDA accepts for review an ImmunityBio supplemental BLA seeking to expand the label for Anktiva (nogapendekin alfa inbakicept-pmln)...

CGMP Deviations at Hangzhou Yiqi Biotechnology

[ Price : $8.95]

FDA warns Chinas Hangzhou Yiqi Biotechnology Co. about CGMP deviations in its manufacturing of active pharmaceutical ingredients.

TEMPO Digital Health Pilot FAQs

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FDA publishes frequently asked questions covering eligibility, statement of interest, and selection of participants for the TEMPO ...

Harbin Jixianglong Biotech API Deviations

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FDA warns Chinas Harbin Jixianglong Biotech about CGMP deviations and other violations in its manufacturing of active pharmaceutic...

Staff Up for Breakthrough Device Recall Oversight: Post

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A Stanford Law School Center for the Law and Biosciences fellow says policymakers should consider the growth in breakthrough medic...

Bayer Gets Priority Review for Stroke Drug

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FDA grants Bayer a priority review for its NDA for asundexian, an investigational oral Factor XIa inhibitor designed to reduce the...

High Court Declines to Hear Medicare Drug Negotiation Challenge

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The U.S. Supreme Court declines to hear a series of pharmaceutical industry challenges to the governments Medicare drug price nego...

FDA Covid-19 Pediatric Review Raises New Scrutiny

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FDA faces renewed scrutiny of an internal FDA analysis of pediatric deaths reported after Covid-19 vaccination, following the rele...