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FDA Grants Accelerated Approval to Rockets Gene Therapy

[ Price : $8.95]

FDA gives Rocket Pharmaceuticals an accelerated approval for its gene therapy Kresladi (marnetegragene autotemcel) for children wi...

FDA Flags Manufacturing/Labeling Violations at STAQ Pharma Ohio Facility

[ Price : $8.95]

FDA sends an untitled letter to STAQ Pharma of Ohio, citing significant manufacturing, quality control, and labeling violations.

FDA Flags Recall of Erbe Flexible Cryoprobes Over Rupture Hazard

[ Price : $8.95]

Erbe USA recalls its flexible cryoprobes due to their potential to rupture during activation, which could result in severe injury ...

Wave Life Sciences Reports Mixed Data on Obesity Therapy

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Wave Life Sciences reports new interim Phase 1 data Thursday indicating that a 240 mg dose of its investigational obesity therapy ...

Podcast Explains New Bayesian Methods Trial Guidance

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On a CDER guidance recap podcast, master mathematical statistician James Travis explains a new draft guidance on using Bayesian me...

FDA Considering Industry PDUFA 8 Incentive Proposal

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FDA meeting minutes say agency representatives in the 2/26 PDUFA 8 reauthorization discussion agreed to consider a proposal from i...

GDUFA Research Helped Product-Specific Guidances: Report

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The FY 2025 report on GDUFA-funded science and research tells how the research supported the development of product-specific guida...

Dont Consider Conflict of Interest Policies in Isolation: Professor

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USC associate professor Genevieve Kanter says she is skeptical that the wholesale firing of HHS advisory committee experts to elim...

Follow Law on Advisory Committees: Petition

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The National Association of Manufacturers calls on FDA to adhere to statutory and regulatory provisions governing expert panel mee...

Watchdog Blasts FDA Over Rising Costs, Higher Rejections

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An advocacy group takes aim at FDA, arguing in a new report that the agencys drug review process has grown more costly and restric...