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17 New, 64 Revised Product-Specific Guidances

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FDA issues 17 new and 64 revised product-specific guidances to aid in developing generic drugs.

Umoja Bio Wins Fast Track for B-Cell Malignancies Drug

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FDA grants Umoja Biopharma a fast track designation for its investigational therapy UB-VV111 for treating relapsed or refractory l...

FDA Complete Response on Menkes Disease Drug

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FDA issues a complete response letter to Fortress Biotech and its majority-owned subsidiary, Cyprium Therapeutics, regarding their...

FDA Approves Novartis Rhapsido for Urticaria

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FDA approves a Novartis NDA for Rhapsido (remibrutinib), a Brutons tyrosine kinase inhibitor for treating adults with chronic spon...

CDRH Proposing 11 Guidances for FY 2026

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CDRH releases a list of 11 final and draft guidances it plans to issue in FY 2026 if resources permit.

Makary Outlines Mission Critical Ops Under Shutdown

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FDA commissioner Marty Makary tells employees affected by the government shutdown that the agency will continue mission-critical a...

AbbVie BLA for Treating Rare Blood Cancer

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AbbVie files a BLA seeking approval for its investigational antibody-drug conjugate pivekimab sunirine to treat blastic plasmacyto...

WLF Wants End to FDA TV Ad Crackdown

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The Washington Legal Foundation calls on the FDA to stop its broad crackdown on drug TV advertising, citing First Amendment protec...

FY 2026 GDUFA Science and Research Priorities

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FDA releases a list of eight Generic Drug User Fee Act science and research priorities for FY 2026, covering 23 separate initiativ...

FDA Clears New Version of UroViu Endoscope

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FDA clears a UroViu 510(k) for its UV5000 cordless, single-use endoscope platform.