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Teleflex Gains Expanded Use on QuikClot Device

[ Price : $8.95]

FDA clears a Teleflex 510(k) for an expanded indication for its QuikClot Control+ Hemostatic Device to include all grades of inter...

Amicis Research Didnt Follow Investigation Plan: FDA

[ Price : $8.95]

FDA warns Dr. Nana Barseghian about a bioresearch monitoring violation in a clinical trial at Northridge, CA-based Amicis Research...

Trump Administration Seeks Mifepristone Case Dismissal

[ Price : $8.95]

The Trump administration asks a federal judge to dismiss a lawsuit filed by three GOP states that seeks to block access to the abo...

Eye Disease Gene Therapy Misses Endpoint: J&J

[ Price : $8.95]

Johnson & Johnson says its gene therapy botaretigene sparoparvovec missed the primary endpoint in the Phase 3 LUMEOS study that is...

Drug Spending Accelerated Last Year: Report

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A new report from IQVIA finds drug spending in 2024 accelerated, with net prices growing at an 11.4% rate last year compared with ...

Experts Dismiss FDA Drug Development Tools Program

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Genentech researchers say FDAs Drug Development Tools Qualification program has had a very limited impact on development programs....

Lab Test Ruling Could Apply to AI at FDA: Researchers

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Public health researchers warn about the broader impacts to emerging technologies (e.g., artificial intelligence) in a March court...

ImmunityBio sBLA Filing Refused on Expanded Indication

[ Price : $8.95]

FDA sends ImmunityBio a refusal to file letter for its recent supplemental BLA submission seeking approval for Anktiva plus Bacill...

Capricor Therapeutics Passes Mid-Cycle Review

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Capricor Therapeutics says it has completed an FDA mid-cycle review meeting on a BLA seeking approval for deramiocel and its use i...

FDA Rejects CytoSorbents Bleed Reducing Device

[ Price : $8.95]

FDA denies a CytoSorbents de novo marketing request for its DrugSorb-ATR antithrombotic removal system, intended for reducing the ...