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FDA Complete Response on Menkes Disease Drug

[ Price : $8.95]

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

FDA Approves Novartis Rhapsido for Urticaria

[ Price : $8.95]

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.

No IND Submitted for Study

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FDA warns San Francisco, CA-based dentist Pamela Den Besten about conducting a clinical trial on an investigational drug without a...

Multiple Violations at Persōn & Covey

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FDA warns Glendale, CA-based Persōn & Covey about CGMP violations in its production of unapproved drugs.