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Breakthrough Status for Uveal Melanoma Therapy

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FDA grants Ideaya Biosciences a breakthrough therapy designation for darovasertib for neoadjuvant use in adult patients with prima...

CRL for Aldeyras Reproxalap for Dry Eye

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FDA issues a complete response letter to Aldeyras NDA for reproxalap to treat dry eye disease, citing a lack of efficacy in the su...

Reorganization Will Block Information Flow

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FDA Webview Contributing Editor John Hope says the dismissal of agency communications staff will hurt information flow to the publ...

Makary Will Face Political Interference Soon: Gottlieb

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Former FDA commissioner Scott Gottlieb predicts just-confirmed FDA commissioner Marty Makary will soon face political interference...

BeiGene Drops Ociperlimab Development in Lung Cancer

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BeiGene scraps the development of BGB-A1217 (ociperlimab), an anti-TIGIT antibody, as a potential treatment for lung cancer.

Accelerated Approval Faces Scrutiny After Cancer Drug Review

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FDAs accelerated approval program faces renewed scrutiny after a recent JAMA study highlighted concerns about cancer drugs that re...

Biogen Gets Fast Track for Alzheimers Therapy

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Biogen wins a fast-track designation for BIIB080, an investigational antisense oligonucleotide therapy for treating Alzheimers dis...

Can FDA Do More With Less?: McClellan

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Former FDA commissioner Mark McClellan says it will be a challenge for the agency to come through the massive reorganization and s...

Industry Sounds the Alarm on FDA Staff Cuts

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Industry associations sound alarms and frustrations as they weigh how FDA staff cuts will impact product development, FDA reviews ...

Ocrevus IV Phase 3 Study Misses Primary Endpoint

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Roche says the Phase 3 MUSETTE study found that a higher dose of Ocrevus IV did not provide more benefit than the approved 600 mg ...