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Nurix Therapeutics Signs $2.3 Billion Roche Collaboration for BTK Degrader Bexobrutideg
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FDA Launches PreCheck Pilot and ANDA Prioritization Program to Accelerate Domestic Manufacturing Reviews
FDA's PreCheck Pilot and ANDA Prioritization programs create structured review incentives for domestically manufactured drugs, with seven companies already enrolled.
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FDA and Reagan-Udall Foundation Convene August 2026 Meeting to Advance Drug Repurposing Selection Criteria
FDA and Reagan-Udall Foundation host an August 2026 hybrid meeting on drug repurposing selection criteria, with public comment open until July 21.
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FDA Draft Guidance Elevates Long-Read Sequencing Requirements for Gene Therapy Genome Editing Safety
FDA draft guidance sets a ~50 bp threshold distinguishing short- from long-read sequencing requirements for genome editing safety assessment in gene therapy submissions.
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