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3 FDA Clinical Trial Guidances Analyzed

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Four Ropes & Gray attorneys identify the key provisions in three new FDA clinical trial modernization guidances.

Regulatory Review Period for Ogsiveo

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for SpringWorks Therapeutics Og...

Pfizer Pulls Oxbryta Sickle Cell Drug

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Pfizer withdraws its sickle cell disease drug Oxbryta from all approved markets after data show the overall benefit does not outwe...

Stakeholder Diversity Action Plan Comments

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Three stakeholder organizations make comments and suggestions for changes in an FDA draft guidance on diversity action plans to in...

Hold Lifted on Biomea Fusion Diabetes Trials

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FDA lifts a clinical hold on Biomea Fusions Phase 1-2 clinical trials of its investigational covalent menin inhibitor BMF-219 in T...

Conflict of Interest Seen in Kisunla Approval

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Investigative journalists write in BMJ about FDA advisory committee members financial conflicts of interest in the consideration o...

Bayer Files Nubeqa sNDA for Prostate Cancer

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Bayer submits a supplemental NDA for oral androgen receptor inhibitor Nubeqa (darolutamide), seeking approval for its use in combi...

ODAC Nixes Checkpoint Inhibitors in Gastric Cancers

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The FDA Oncology Drugs Advisory Committee votes not to recommend using immune checkpoint inhibitors in first-line advanced gastric...

Info Collection on Device Recall Authority

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Federal Register notice: FDA sends to OMB an information collection extension entitled Medical Device Recall Authority.

Merck Favezelimab/Keytruda Trial Misses Endpoint

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Merck says a trial assessing favezelimab and Keytruda (pembrolizumab) failed to meet its primary endpoint in patients with previou...