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HHS Seeks Input on Categories of Federal Vaccine Recommendations

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HHS seeks input on how the federal government classifies vaccine recommendations, including whether its current system gives patie...

FDA 3-Month Review Extension on Capricor Gene Therapy

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FDA extends by three months its review of a Capricor Therapeutics BLA for Deramiocel, an investigational cell therapy for Duchenne...

Study Finds Severe Liver Injury in Small Number of Avacopan Patients

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As Amgen continues its bid to prevent the withdrawal of Tavneos (avacopan) in the U.S., a new study finds that while liver enzyme ...

Clinical Hold on Regenxbio Hunter Syndrome Gene Therapy

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FDA places a clinical hold on Regenxbio's investigational gene therapy RGX-121 after asymptomatic spine MRI findings were identifi...

Early Alert on CooperSurgical Neonatal CPAP Ventilator

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FDA issues an early alert about a potentially high-risk problem involving certain CooperSurgical INCA neonatal and infant nasal co...

Roche/Lilly Alzheimers Test Cleared

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FDA clears Roche/Eli Lillys Elecsys Phospho-Tau (217P) Plasma (pTau217) blood test as a single blood-based option to aid in identi...

CBER Updates Process for Formal Disputes With Sponsors

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CBER updates its standard operating procedures for resolving scientific/procedural disputes between sponsors and the Center, estab...

Scholar Rock Removes Catalent Facility from BLA to Advance Apitegromab

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Scholar Rock says it has made further regulatory progress for apitegromab, its investigational treatment for spinal muscular atrop...

Lawmakers Urge FDA to Up Scrutiny of Clinical Data From China

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House Select Committee on China chairman John Moolenaar (R-MI) and Rep. Ben Cline (R-VA) are urging FDA intensify safeguards on cl...

FDA Issues New Guidance on Therapeutic Equivalence Evaluations

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FDA issues a final guidance describing how it evaluates therapeutic equivalence among prescription drug products and assigns thera...