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House Hearing Previews Debate Over FDA Modernization, User Fees

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House Energy and Commerce Health Subcommittee leaders reveal differing views over whether the Trump administration's policies are ...

A New Era of Innovation for FDA Public Health Pillars

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FDA acting commissioner Kyle Diamantas positions the agencys four public health pillars as a means to fulfill its enduring mission...

VAI Close Out for HLB Inspection

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A Cancer Network post says FDA issued a voluntary action indicated close-out letter to HLB following a CGMP inspection at a facili...

Kennedy Wanted Sentinel, BEST Data: Reuters

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A Reuters deep dive into HHS secretary Robert F. Kennedy Jr.s efforts to eliminate childhood vaccine requirements says his aides a...

Priority Review for Gazyva sBLA for Primary Membranous Nephropathy

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FDA grants Roche a priority review for its supplemental BLA seeking approval for Gazyva (obinutuzumab) for treating adults with pr...

Axsome NDA for Cataplexy in Patients with Narcolepsy

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FDA accepts for review an Axsome Therapeutics NDA for AXS-12 (reboxetine) for treating cataplexy in patients with narcolepsy.

CGMP Issues Found at International Medication Systems

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FDA warns South El Monte, CA-based International Medication Systems about CGMP violations in its production of finished drugs.

Multiple Violations in ZIIP Inspection

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FDA warns Pleasant Hill, CA-based ZIIP Inc. about Quality System violations in its production of adulterated and misbranded unappr...

Biogen Defends Anti-Tau Alzheimer's Data After Investor Selloff

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Biogen executives attempt to reassure investors Tuesday that its experimental anti-tau Alzheimer's disease therapy remains a promi...

Keep Safety and Dosing Info in Valtoco Label: Petition

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Neurelis petitions FDA to ensure that any generic version of diazepam nasal spray is no less safe and effective than its Valtoco f...