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Xenon Reports Positive Phase 3 Data for Epilepsy Drug

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Xenon Pharmaceuticals says its experimental epilepsy drug azetukalner met the primary endpoint in a late-stage clinical trial in p...

Updated Guidance Clarifies Biosimilar Development Requirements

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FDA posts an updated draft guidance outlining new and revised recommendations for companies developing biosimilar products.

Incyte Gets Complete Response Over Catalent Inspection Issues

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FDA sends Incyte a complete response letter for its supplemental BLA for Zynyz (retifanlimab-dlwr) injection that cited inspectio...

Group urges Pfizer to Retract Threat on Drug Supplies

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Consumer advocacy group Public Citizen urges Pfizer to commit to maintaining access to its medicines in Europe after comments by C...

Roche Breast Cancer Drug Misses Endpoint in Late-Stage Trial

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Roche reports that its investigational breast cancer drug giredestrant failed to significantly extend progression-free survival in...

FDA Meets with States to Advance Canada Importation Plan

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FDA says it recently held a meeting with several states to discuss implementation of a program that would allow the importation of...

Ipsen Withdraws Tazverik Over Safety Data

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Ipsen voluntarily withdraws Tazverik (tazemetostat) from the market based on emerging data from the ongoing Phase 1b/3 SYMPHONY-1 ...

FDA Cites Documentation Lapses at Maiva Pharma

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FDA investigators cite manufacturing and documentation issues at an Indian sterile drug facility operated by Maiva Pharma Private ...

Public Trusts FDA Career Scientists Over Agency Leadership

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A new national survey sees Americans expressing significantly greater confidence in FDA career scientists than in the leaders who ...

FDA Biologics Chief Vinay Prasad to Step Down in April

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HHS says CBER director Vinay Prasad will step down at the end of April.