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Food and Drug Administration

Aurion Biotech Receives Breakthrough Therapy Designation and Regenerative Medicine Advanced Therapy Designation for Its Drug Candidate AURN001

Aurion Biotech, whose mission is to restore vision to millions of patients with life-changing regenerative therapies, announced that the U.S. Food and Drug Administration...

Sentynl Therapeutics Announces Global Acquisition of Zokinvy® (Lonafarnib) for Treatment of Hutchinson-Gilford Progeria Syndrome from Eiger BioPharmaceuticals

Sentynl Therapeutics, Inc., a U.S.-based biopharmaceutical company wholly-owned by Zydus Lifesciences, Ltd. (Zydus Group), and Eiger BioPharmaceuticals, Inc., a commercial-stage biopharmaceutical company focused on the development of...

FDA Approves First Cellular Therapy to Treat Patients with Type 1 Diabetes

The U.S. Food and Drug Administration approved Lantidra, the first allogeneic (donor) pancreatic islet cellular therapy made from deceased donor pancreatic cells for the...

FDA Approves Innovative 4D Flow MRI Blood Flow Analysis Software from Cardio Flow Design Inc. (Japan) – Enhance Cardiovascular Diagnostic Accuracy

The US Food and Drug Administration has approved the use of iTFlow in blood flow analysis. The FDA approval is significant as it recognizes...

MedCrypt and Stratigos Security Partner to Offer Specialized Penetration Testing and Security Assessments for Life-Saving Medical Devices

MedCrypt Inc., the proactive cybersecurity solutions provider for medical device manufacturers, including seven of the top 10, they announced its partnership with Stratigos Security,...
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