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FDA Seeks Input on Statistical Flexibility in Rare Disease Trials

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FDA seeks input on whether traditional statistical standards should be modified for rare disease clinical investigations, includin...

Lytenava OK Offers Lessons on FDAs Use of Confirmatory Evidence

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FDAs approval of Outlook Therapeutics Lytenava shows that the agencys willingness to accept one adequate and well-controlled trial...

Enhertu Cuts Progression Risk 37% in Lung Cancer Trial

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AstraZeneca and Daiichi Sankyo says that Enhertu cut the risk of disease progression or death by 37% compared with pembrolizumab (...

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...

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...

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...