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CDER Division of Applied Regulatory Science (DARS) has published its 2025 Annual Report, highlighting significant research advance...[ Price : $8.95]
Rep. Josh Gottheimer introduces several bills to mark Rare Disease Week.[ Price : $8.95]
FDA releases a list of 81 new and revised guidances in 12 categories that CDER plans to issue this calendar year.[ Price : $8.95]
FDA warns Ross Healthcare, in Lynden, WA, about CGMP violations in its production of finished drugs.[ Price : $8.95]
FDA accepts for review a Vanda Pharmaceuticals BLA for imsidolimab, a potential new treatment for generalized pustular psoriasis.[ Price : $8.95]
Fresenius Kabi recalls its Ivenix Large Volume Pump due to a software issue.[ Price : $8.95]
FDA grants Array BioPharma a traditional approval for its previously accelerated-approved Braftovi (encorafenib) for use in combin...[ Price : $8.95]
Novo Nordisk reports favorable weight-loss data with its triple agonist UBT251 in a Phase 2 trial in China.