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Guide on Covariate Adjustments in Trials

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Federal Register notice: FDA makes available a final guidance entitled Adjusting for Covariates in Randomized Clinical Trials for ...

BMS Breyanzi Deep and Durable Efficacy

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Bristol Myers Squibb says its Breyanzi showed positive results in a Phase 1/2 trial in patients with relapsed or refractory chroni...

Progression-Free Survival Improves in DUO-E Trial: AZ

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AstraZeneca says the Phase 3 DUO-E trial showed significant progression-free survival of endometrial cancer with its Imfinzi plus ...

3 Observations in UCB Pharma FDA-483

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FDA releases the form FDA-483 with three observations from an inspection at the UCB Pharma drug manufacturing facility in Braine-l...

Updated Boxed Warning for Rx Stimulants

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FDA requires updates to Boxed Warnings for prescription stimulants indicated to treat ADHD and other conditions.

Comments on Gene, Cell Therapy Surveillance

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Three stakeholders comment and make recommendations following an FDA listening session on methods and approaches for capturing pos...

Heparin Sodium Not Withdrawn for Safety/Efficacy

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Federal Register notice: FDA determines that a Fresenius Kabi NDA for heparin sodium injection was not withdrawn for reasons of sa...

Berlin Heart Recalls Excor Heart Pump

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Germany-based Berlin Heart recalls its Excor Pediatric Ventricular Assist Device Blood Pumps due to the potential for therapy disr...

Colorectal Cancer NDA Gets Priority Review

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FDA accepts for priority review a Takeda and Hutchmed NDA for fruquintinib, indicated for treating adult patients with previously ...

Neuralink Says FDA OKs Brain Implant Trial

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Elon Musks Neuralink says FDA has approved a human trial for its brain implant technology to be used to control external technolog...