DRAWBRIDGE SECURES FDA 510(K) CLEARANCE FOR AT-HOME BLOOD SAMPLING DEVICE NANODROP
Drawbridge Health, a healthcare technology company focused on reinventing the blood draw experience, today announced that its at-home, patented blood sampling device, NanoDrop, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Over-the-Counter use. The clearance of this…
The World’s First “Recombinant Anthrax Vaccine”: GC Biopharma applies for MFDS Approval
GC Biopharma announced 1 Nov. 2023 that it has applied for the marketing approval of “GC1109”, an anthrax vaccine jointly developed by GC Biopharma and the Korea Disease Control and Prevention Agency (KDCA), to the Korean Ministry of Food and Drug Safety…
RedHill Announces FDA sNDA Approval for Talicia®
RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, announced the U.S. Food and Drug Administration’s (FDA) approval of its supplemental new drug application (sNDA) for Talicia[3], allowing a change to a more flexible three times…