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Bimagrumab Enhances Weight Loss: Study

[ Price : $8.95]

New data from a Phase 2 study on Eli Lillys experimental bimagrumab showed that when combined with Novo Nordisk's Wegovy (semaglut...

Guideline on Drug Stability Testing Released

[ Price : $8.95]

FDA posts an International Council for Harmonization draft guideline entitled Stability Testing of Drug Substances and Drug Produc...

Inspections Help Prevent Drug Shortages: Study

[ Price : $8.95]

A new study disputes previous assumptions about FDA inspections leading to more drug shortages at facilities receiving GMP citatio...

Daiichi Sankyo Drug OKd for Lung Cancer

[ Price : $8.95]

FDA approves a Daiichi Sankyo BLA for Datroway (datopotamab deruxtecan-dlnk) for certain adults with locally advanced or metastati...

Medline Issues Correction for Procedure Kits

[ Price : $8.95]

Medline Industries recalls certain lots of its medical procedure kits that include recalled Medtronic Aortic Root Cannulas due to ...

Is FDA Going After RUO Diagnostics?

[ Price : $8.95]

Two SheppardMullin attorneys say it remains to be seen whether a recent FDA Warning Letter to DRG Instruments about selling resear...

FDA Halts Some Cell Clinical Trials

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FDA says it is reviewing all clinical trials that rely on a Biden administration exemption that allowed sensitive biological mater...

Top 2 FDA Cell/Gene Therapies Officials Pushed Out

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FDA places CBER Office of Therapeutic Products director Nicole Verdun and her deputy Rachael Anatol on administrative leave in the...

Securing Technology, Equipment Report

[ Price : $8.95]

The FDA Office of Regulatory and Emerging Science publishes a report describing agency efforts to research cybersecurity and advan...

Dupixent Approved for Bullous Pemphigoid

[ Price : $8.95]

FDA has approved Sanofi and Regenerons Dupixent (dupilumab) for treating adult patients with bullous pemphigoid that mainly affect...