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QS, MDR Violations at S. Koreas Aju Pharm

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FDA warns South Koreas Aju Pharm about QS and MDR violations in its production of two Class 2 medical devices.

FDA Skips Panel Review for Capricor Cell Therapy

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FDA says there will be no advisory committee review of Capricor Therapeutics BLA for Deramiocel, the companys lead cell therapy ca...

CDER Acting Head Corrigan-Curay Leaving in July

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CDER acting director Jacqueline Corrigan-Curay decides to retire and will leave her post next month.

GE Recalls Carestation Anesthesia Devices

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GE HealthCare recalls certain Carestation anesthesia devices due to the risk that they may not provide effective ventilation in ce...

Bimagrumab Enhances Weight Loss: Study

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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

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

Inspections Help Prevent Drug Shortages: Study

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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

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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

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

Dupixent Approved for Bullous Pemphigoid

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