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FDA Division of Applied Regulatory Science Releases Annual Report

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CDER Division of Applied Regulatory Science (DARS) has published its 2025 Annual Report, highlighting significant research advance...

Rep. Gottheimer Introduces 5 Bipartisan Rare Disease Bills

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Rep. Josh Gottheimer introduces several bills to mark Rare Disease Week.

CDER Plans 81 New, Revised Guidances in 2026

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FDA releases a list of 81 new and revised guidances in 12 categories that CDER plans to issue this calendar year.

5 CGMP Issues Cited in Ross Healthcare Inspection

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FDA warns Ross Healthcare, in Lynden, WA, about CGMP violations in its production of finished drugs.

FDA Accepts Vanda BLA for Rare Skin Disorder Drug

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FDA accepts for review a Vanda Pharmaceuticals BLA for imsidolimab, a potential new treatment for generalized pustular psoriasis.

Fresenius Recalls Ivenix Pumps Over Software Issue

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Fresenius Kabi recalls its Ivenix Large Volume Pump due to a software issue.

Array Wins Full Approval for Colorectal Cancer Therapy

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FDA grants Array BioPharma a traditional approval for its previously accelerated-approved Braftovi (encorafenib) for use in combin...

Novo Nordisk Triple G Weight Loss Drug Shows Promise

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Novo Nordisk reports favorable weight-loss data with its triple agonist UBT251 in a Phase 2 trial in China.

Immedica Gains Accelerated OK for Arginase 1 Deficiency Therapy

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FDA grants Immedica Pharma an accelerated approval for its BLA for Loargys (pegzilarginase-nbln), the first therapy specifically d...

Beta Bionics Gets Warning on iLet Bionic Pancreas

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FDA issues Beta Bionics a Warning Letter, citing wide-ranging quality system, complaint handling, reporting, and recall-related vi...