Theradaptive Strengthens Executive Team with Hire of Frank Vizesi as Chief Scientific Officer Frank brings over 20 years experience in cutting-edge orthobiologics research, with previous roles at NuVasive, SeaSpine and [….]
Measuring Quality System Maturity & Its Significance The article originally appeared on PQE’s website and is written by Davide Buratti, GxP Compliance Operations Director & Partner @ PQE Group. Read [….]
Use of Electronic Signatures in the FDA-Regulated Industry with 21 CFR Part 11 Compliance By Gina Casallas, PQE Group Senior Consultant, CSV | September 20, 2023 Due to the increase [….]
Hepion’s Phase II NASH Study Hits Primary and Secondary Endpoints By Mark TerryMay 23, 2024 Non-alcoholic steatohepatitis (NASH) has been a very tough nut to crack, with numerous companies’ compounds [….]
FDA Approves First-Ever Drug for Agitation Associated with Alzheimer’s Dementia By Mark TerryMay 11, 2023 The U.S. Food and Drug Administration approved the supplemental New Drug Application (sNDA) for Rexulti [….]
Jeff Galvin, the CEO of American Gene TechnologiesⓇ, one of the leading biotech companies in Maryland, has championed the state as “DNA Valley.” And Galvin should know: he came to Maryland after a successful career in Silicon Valley and sees parallels between the early days of an emerging Silicon Valley and what’s going on today in DNA Valley, which currently stretches from Montgomery County and Frederick, Maryland all the way up to Baltimore.
Theradaptive, a privately held biopharmaceutical company pioneering a new class of regenerative implants announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Medical Device designation to its Osteo-Adapt SP Spinal Fusion implant indicated for transforaminal lumbar interbody spinal fusion to treat degenerative disc disease, spondylolisthesis, or retrolisthesis.
QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced it has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its QIAreach® SARS CoV-2 Antigen Test, which is designed for environments that require a high volume of fast and accurate test results.
University of Maryland Fischell Department of Bioengineering professor and chair John Fisher is working with the U.S. Food and Drug Administration (FDA) to undertake regulatory research into emerging cardiac electrophysiology medical device technologies and human-induced pluripotent stem cells (hiPSCs) to assess device safety and efficacy.
United Therapeutics Corporation (Nasdaq: UTHR) today announced that the U.S. Food and Drug Administration (FDA) accepted for priority review the New Drug Application (NDA) for Tyvaso DPI™ (inhaled treprostinil) for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). United Therapeutics expects the agency’s review to be complete in October 2021. FDA also indicated that they have not identified any potential review issues at this time.
