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House Republicans Want GAO Lab Safety Review

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House Energy and Commerce Committee Republicans ask for a GAO review of laboratory safety in FDA, CDC, and NIH, citing previous GA...

FDA Warns Taiwanese, Australian X-ray Firms

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FDA warns two firms in Taiwan and Australia about Quality System violations in their manufacturing of x-ray equipment.

Complete Response Letter on Ocaliva sNDA

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FDA sends Intercept Pharmaceuticals a complete response letter on its supplemental NDA for Ocaliva (obeticholic acid) seeking to c...

Disappointed Califf on Possible Disruption at FDA

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FDA commissioner Robert Califf tells Friends of Cancer Researchs annual meeting that he is personally disappointed in the election...

Lilly Opposes Tirzepatide Bulks List Nomination

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Lilly calls on FDA to reject the Outsourcing Facilities Association nomination of tirzepatide to be on the 503 Bulks List so it ca...

Clinical Hold on Novavax Vaccines Lifted

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FDA removes a clinical hold on a Novavax IND for its Covid-19-influenza combination and stand-alone flu vaccine candidates.

Autolus Wins OK for Leukemia CAR-T Theray

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FDA approves an Autolus Therapeutics BLA for Aucatzyl (obecabtagene autoleucel), a CAR-T therapy for treating adult patients with ...

Safety Issue Prompts Zelnecirnon Termination

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Rapt Therapeutics terminates its zelnecirnon drug development program due to a serious liver safety issue.

J&Js Nipocalimab Gets Breakthrough Status

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FDA grants Johnson & Johnson a breakthrough therapy designation for nipocalimab and its use for treating Sjgren's disease.

Disappointing Data in Schizophrenia Drug: AbbVie

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AbbVie says its two Phase 2 EMPOWER trials investigating emraclidine as a once-daily, oral monotherapy treatment for adults with s...