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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.

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...

Pallone Asks GAO to Analyze RIF Impact on User Fees

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House Energy and Commerce Committee ranking member Frank Pallone asks the Government Accountability Office to analyze how FDA paid...

Yale, Harvard Experts Call for Greater FDA Transparency To Rebuild Public Trust

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A group of academic and public health experts urges FDA to embrace greater transparency, scientific independence and regulatory co...

Full Approval Given to Lilly's Retevmo

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FDA converts the accelerated approval of Eli Lilly's Retevmo (selpercatinib) into a traditional approval for treating adult and pe...