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Group Calls for Policy Changes to Sustain Generic, Biosimilar Competition

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A new report from the Association for Accessible Medicines calls for changes to FDA policies, patent law, pharmacy benefit manager...

Pharming Groups Joenja Gets Expanded Approval

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FDA grants Pharming Group expanded approval for Joenja (leniolisib) tablets for treating activated phosphoinositide 3-kinase delta...

Exelixis NDA Review Extended for Colorectal Cancer Drug

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FDA extends by three months its review of an Exelixis NDA for zanzalintinib, in combination with atezolizumab, for treating patien...

FDA Oncology Chief to Focus on AI, Streamlined Drug Development

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Oncology Center of Excellence director Angelo de Claro says the center will build on initiatives established under longtime and fo...

FDA-SEC Info Sharing Raises Disclosure, Insider Trading Concerns

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A Sheppard analysis warns that regulated industry should expect closer scrutiny of statements about FDA interactions and broaden t...

Priority Review for Roche Enspryng sBLA

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FDA grants a priority review for a Roche sBLA for Espryng to treat myelin oligodendrocyte glycoprotein antibody-associated disease...

BMC Medical Recalls Sleep Apnea Machines

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BMC Medical recalls its Luna G3 APAP (Model LG3600), an auto-adjusting positive airway pressure machine for treating obstructive s...

FDA Partial Clinical Hold on Biohaven Epilepsy Drug

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FDA issues a partial clinical hold on Biohavens opakalim (BHV-7000) due to nonclinical characterization of certain metabolites doc...

3 Observations on XeCare FDA-483

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FDA releases the Form FDA-483 with three observations from an inspection at New Albany, OH-based XeCare.

FDA Open to Alternative Approaches For Psychedelic Drug Trials

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Writing in a in a New England Journal of Medicine article, FDA officials encourage novel approaches for developing psychedelic dru...