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Abeona Skin Disorder BLA Resubmission Accepted

[ Price : $8.95]

FDA accepts for review an Abeona Therapeutics BLA resubmission for prademagene zamikeracel (pz-cel), a gene therapy for patients w...

Nuplazid Not Withdrawn Over Safety/Efficacy

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Federal Register notice: FDA determines that Nuplazid (pimavanserin tartrate) tablet (equivalent 17 mg base) was not withdrawn due...

Workshop on Optimizing Real-World Evidence Use

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Federal Register notice: FDA announces a 12/12 public workshop titled Optimizing the Use of Real-World Evidence in Regulatory Deci...

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...

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.