Abbott Laboratories, a multinational health care and medical device company, announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA), making history as the first ever handheld blood test for traumatic brain injuries (TBIs). The...
On Wednesday (1/6) the U.S. Food and Drug Administration (FDA) announced that it is tracking the COVID-19 testing diagnostics with SARS-CoV-2 test developers to determine the efficacy of the already-approved tests on their ability to detect new COVID-19 variants. The...
Today (1/7) Gemini Therapeutics announced that the U.S. Food and Drug Administration (FDA) granted GEM103 treatment of dry age-related macular degeneration (AMD) for Fast Track designation. Gemini Therapeutics is a clinical stage precision medicine company based in...
The U.S. Food and Drug Administration (FDA) released a statement on Monday (1/4) urging healthcare providers to follow the approved dosing schedules for COVID-19 vaccinations, after discussions of changing doses, limiting doses, and extending length of time in between...
Today (1/5) BioSerenity announced that the U.S. Food and Drug Administration (FDA) cleared the Neuronaute® EEG System and IceCap® EEG wearable device. The device is designated for patients diagnosed with epilepsy, and will enable physicians to remotely monitor and...
Antengene submitted yesterday (1/3) a New Drug Application (NDA) with Orphan Drug Designation (ODD) to South Korea’s regulatory body, the Ministry of Food and Drug Safety (MFDS), for ATG-010 (selinexor). The NDA is specifically for the approval of ATG-010 (selinexor)...
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