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Cogent Bio Plans NDA for Bezuclastinib

[ Price : $8.95]

Cogent Biosciences says FDA has agreed to accept the companys planned NDA for cancer drug bezuclastinib under the agencys Real-Tim...

Moderna/Merck Report Positive Data on Melanoma Vaccine

[ Price : $8.95]

Moderna and Merck report updated five-year follow-up data that show their personalized mRNA cancer vaccine candidate, intismeran a...

FDA Seeks More Data on Capricor Cell Therapy

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FDA asks Capricor Therapeutics for a full clinical study report from the companys Phase 3 HOPE-3 trial as part of its ongoing BLA ...

ICH Drug Submission Quality Information Guidance

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FDA publishes for review and comment the International Council for Harmonization M4Q(R2) guidance establishing the location and st...

4 CGMP Issues at Integrity Partners Facility

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FDA warns Integrity Partners St. Louis, MO-based Chemisphere drug manufacturing facility about CGMP issues in its production of fi...

Valneva Withdraws BLA for Chikungunya Vaccine

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Valneva says it has voluntarily withdrawn its BLA for Ixchiq, the companys chikungunya vaccine, based on FDA safety-related restri...

Celcuity NDA Gets Priority Review for Breast Cancer

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FDA accepts for priority review a Celcuity NDA for gedatolisib in patients with hormone receptorpositive, HER2-negative, PIK3CA wi...

Objectionable Conditions in Prodrome Sciences BIMO Inspection

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FDA warns Temecula, CA-based Prodrome Sciences USA about violations in its conduct of a clinical trial without submitting an IND.

Guide on Endpoints for Multiple Myeloma Accelerated Approval

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FDA posts a draft guidance outlining how drug developers can use minimal residual disease and complete response as primary endpoin...

Novo Nordisk Supplements Semaglutide Petition

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Novo Nordisk submits to FDA additional studies and analyses it says support its petition asking the agency to act against compound...