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FDA approval

Reporting, analysis and commentary on FDA approval from Authentica Global, drawn together from across our coverage.

3 articles Latest update: 5 Jul 2026 1 section
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Related topics gedatolisib breast cancer FDA verdict gedatolisib Celcuity breast cancer PI3K inhibitors VIKTORIA-1
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FDA headquarters signage representing the pending regulatory decision on gedatolisib for advanced breast cancer
Health

Gedatolisib Breast Cancer FDA Verdict Nears for Patients Out of Options

Gedatolisib, Celcuity's PI3K/mTOR inhibitor, faces a July 17, 2026 FDA decision that could deliver the first targeted therapy for HR-positive, PIK3CA wild-type advanced breast cancer patients with no options after CDK4/6 and hormone therapy.

5 Jul 2026 ·8 min read
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More paths through this story

This archive gathers Authentica Global coverage of FDA approval, bringing together the reporting, analysis and commentary connected to the subject.

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gedatolisib breast cancer FDA verdict gedatolisib Celcuity breast cancer PI3K inhibitors VIKTORIA-1 IgA nephropathy atacicept FDA decision Vera Therapeutics atacicept kidney disease

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