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Bridge to Life Ltd. Receives Breakthrough Device Designation from the FDA

Bridge to Life, Ltd. ("Bridge to Life" or the "Company"), a leading global supplier of organ preservation solutions and organ perfusion technologies, announced breakthrough...

FDA Granted CMG901 Fast Track Designation for Unresectable or Metastatic Gastric and Gastroesophageal Junction Cancer

Keymed Biosciences announced that the U.S. Food and Drug Administration (FDA) granted CMG901 Fast Track Designation as monotherapy for the treatment of unresectable or...

FDA Accepts Dupixent for Priority Review in Patients Aged 12 Years and Older with Eosinophilic Esophagitis

Regeneron Pharmaceuticals, Inc. and Sanofi announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA)...

U.S. FDA Grants Priority Review to Genentech’s Actemra for the Treatment of COVID-19 in Hospitalized Adults

Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application...

Gadopiclenol Marketing Authorization Dossier Submissions Accepted for Review by EMA and FDA

Guerbet , a global leader in medical imaging offering a comprehensive range of pharmaceutical products, medical devices, and digital and artificial intelligence (AI) solutions...
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