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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...

Kodiaks Zenkuda Posts 2nd Phase 3 Win in Diabetic Retinopathy

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Kodiak Sciences says its anti-VEGF therapy Zenkuda (tarcocimab tedromer) hit the mark in a second Phase 3 trial in diabetic retino...

Experts Highlight FDAs Push for Bespoke Genetic Therapy Pathway

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Health experts breakdown a new FDA policy framework that could mark a turning point for highly individualized genetic medicines.

Multiple Violations at Longhorn Vaccines and Diagnostics

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FDA warns Bethesda, MD-based Longhorn Vaccines and Diagnostics about Quality System, Medical Device Reporting, and Adulterated and...

FDA Asks for Rezolutes Ersodetug Data After Trial Miss

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FDA asks to look at Rezolutes Phase 3 data after the companys trial of ersodetug missed the primary endpoint, with the hope of cha...

FDA Open to Single Phase 3 for Netherton Syndrome Drug

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Quoin Pharmaceuticals says FDA has signaled openness to a streamlined development path for its rare disease candidate QRX003, indi...

Beam Eyes Accelerated Approval for Genetic Disease Therapy

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Beam Therapeutics says it will advance its base-editing therapy BEAM-302 into pivotal development to seek accelerated approval for...

4 Observations on Micro Labs 483

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FDA releases the form FDA-483 issued following an inspection at the Micro Labs drug manufacturing facility in Bengaluru, Karnataka...