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FDA Backs Monovalent XBB.1.5 Covid Vaccine

[ Price : $8.95]

FDA advises manufacturers that they should develop vaccines with a monovalent XBB.1.5 composition, according to a notice posted on...

Reps. Introduce Drug Labeling Bill

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Reps. Schiff and Kuster introduce legislation to direct FDA to establish a process to allow generic drug manufacturers to update d...

Panel Backs Monovalent XBB Variant Covid Vaccine

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FDAs Vaccines and Related Biological Products Advisory Committee votes 21 to 0 that the Covid-19 vaccination program for the 2023-...

AI/ML Challenges in Precision Medicine: FDA Paper

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FDA researchers discuss ways to improve the use of AI/ML in precision medicine.

Corvus Wants FDA Meeting on CPI-818 Trial

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Corvus Pharmaceuticals seeks a 3rd quarter meeting with FDA to discuss a Phase 3 trial for its investigational cancer drug CPI-818...

Conditional Approval for Marginal New Drugs: Avorn

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Harvard Medical School professor Jerry Avorn says FDA needs to take a nonbinary approach to some drug approvals with a conditional...

FDA OKs Amendment to Uproleselan Trial

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FDA clears a Phase 3 protocol amendment to allow a time-based analysis of Glycomimetics uproleselan if sufficient survival events ...

Public Citizen Urges FDA to Reject Duchenne BLA

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Public Citizens Health Research Group urges FDA to not grant accelerated approval to Sarepta Therapeutics gene therapy SRP-9001 fo...

American Labs Bowel Disease Assay Cleared

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FDA clears an American Laboratory Products 510(k) for its Calprotectin Immunoturbidimetric Assay as an aid in diagnosing inflammat...

FDA Partial Hold on Mersana Trials

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FDA issues a partial clinical hold against Mersana Therapeutics clinical trials of UpRi (upifitamab rilsodotin) in platinum-sensit...