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Direct Biologics | April 13, 2022
Direct Biologics, an innovative biotechnology company with a groundbreaking extracellular vesicle platform drug technology, announced that the U.S. Food and Drug Administration has awarded their EV drug product ExoFlo with a Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of Acute Respiratory Distress Syndrome associated with COVID-19. The RMAT program is designed to expedite the approval of promising regenerative medical products in the US that demonstrate clin...
Research
Newswire | July 05, 2023
Cipher Pharmaceuticals Inc. ("Cipher" or "the Company") today announced that the Company's partner, Moberg Pharma AB, ("Moberg Pharma") has obtained European Union approval for MOB-015 (nail fungus treatment) as a result of demonstrating superior levels of mycological cure (76% vs. 42% for comparators) and a significantly better complete cure rate. MOB-015 has been recommended for national approval in 13 European countries, which will be commerc...
Pharma Tech
Lantheus | February 07, 2023
On February 6, 2023, Lantheus Holdings, Inc. (Lantheus), a company dedicated to improving patient outcomes through radiotherapy, diagnostics, and AI solutions that help clinicians to Find, Fight, and Follow® diseases, announced the acquisition of Cerveau Technologies, Inc. (Cerveau). Cerveau's primary asset is MK-6240, which is a second-gen F 18-labeled positron emission tomography (PET) imaging agent that targets Tau tangles present in Alzheimer's disease. ...
Pharmacy Market
Fusion Pharmaceuticals | June 03, 2021
Fusion Pharmaceuticals Inc., a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines; today announced it entered a 15-year lease agreement with Hamilton, Ontario-based McMaster University, to build a 27,000 square foot Good Manufacturing Practice (GMP) compliant radiopharmaceutical manufacturing facility. The facility, to be made by McMaster and equipped and validated by Fusion, will be designed to support the manufacturing of the Compa...
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