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OPDP Study on Accelerated Approval Info DTC Web Sites

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CDERs Office of Prescription Drug Promotion proposes to conduct a study entitled Accelerated Approval Disclosures on Direct-to-Con...

FDA Withdraws Farydak Over Confirmatory Study

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Federal Register notice: FDA withdraws approval of a Secura Bio NDA for Farydak (panobinostat) capsules after the company requeste...

Legislation for More AI/ML Flexibility Needed: Shuren

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CDRH director Jeffrey Shuren says legislation is needed to provide more regulatory flexibility and agility to deal with artificial...

Former FDA Vaccine Official Joins Mesoblast Board

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Former CBER Office of Vaccines Research and Review deputy director Philip Krause joins Mesoblasts board of directors and will assi...

Breakthrough Designation for Pfizer RSV Vaccine Candidate

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FDA grants a second breakthrough designation to Pfizers respiratory syncytial virus vaccine candidate, this time to prevent lower ...

FDA Oks Change to Cabenuva Start-up Regimen

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FDA approves a label update for Janssens Cabenuva to permit starting the injection treatment without an oral treatment lead-in.

FDA Rejects Lilly BLA on Me-too PD-1 Inhibitor

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FDA sends Eli Lilly and Innovent Biologics a complete response letter on its BLA for sintilimab injection, a me-too PD-1 inhibitor...

FDA Schedules Generic Drug Forum

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FDA announces the dates and program for the Generic Drugs Forum 2022.

FDA Approves Novartis Pluvicto for Prostate Cancer

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FDA approves Novartis Pluvicto for treating some prostate cancers and approves a radioactive diagnostic agent to identify candidat...

Amylyx ALS Drug May Cause FDA Problems: AP

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An Associated Press report says an upcoming FDA advisory committee meeting to consider an Amylyx drug to treat ALS may raise issue...