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...
With a population of more than 1.3 billion people, India is one of the fastest growing economies in the world. As their global economy continues to expand, and as clinical trials are continuing to be conducted overseas, India remains unique in both the opportunities...
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)...
According to Operation Warp Speed Chief, Moncef Slaoui, the AstraZeneca and Oxford University vaccine may not receive the U.S. Food and Drug Administration’s Emergency Use Approval (EUA) until April, despite the UK’s approval yesterday (12/30). Questions...
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