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Complete Response Letter on Sanofi BLA

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FDA sends Sanofi a complete response letter on its BLA for sutimlimab, an investigational monoclonal antibody for treating hemolys...

Changes Needed for Future Infectious Disease Issues: Woodcock

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Operation Warp Speeds Janet Woodcock says a lesson learned from the Covid-19 experience is the need to establish infectious diseas...

Heron Resubmits HTX-011 Pain Drug NDA

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Huron Therapeutics says it has resubmitted to FDA its NDA for HTX-011, an investigational non-opioid analgesic indicated for treat...

FDA Clears Lantheus Bone Scan Index

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FDA clears the Lantheus automated bone scan index to be used on the GE Healthcare Xeleris platform.

Two Nexus Suits Invoke Buckman Implied Preemption

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Attorney James Beck says a California federal court dismissed two Nexus Pharmaceutical suits against drug compounders due to impli...

FDA Designates Agios Mitapivat Orphan Drug

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FDA grants an additional orphan drug designation for Agios mitapavit for treating sickle cell disease.

Indivior Paying $289 Million for Unlawful Suboxone Marketing

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The Justice Department says Indivior Solutions was sentenced to pay $289 million under a plea agreement for criminal charges invol...

FDA FY 21 Budget Initiatives Analyzed

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The Alliance for a Stronger FDA lists six programs likely to get additional funding from the FY 21 agency budget.

License for Mass Spectrometry for Covid, Other Uses

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Federal Register notice: FDA contemplates the grant of an exclusive patent license to Advion, Inc. (Ithaca, NY) for a government-o...

Safety Labeling Change Posted for Ocrevus

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FDA posts a safety labeling change for Genentechs Ocrevus.