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...
NeuroRx and Relief Therapeutics have completed enrollment for their phase 2b/3 clinical trial for their treatment of respiratory failure in patients with severe cases of COVID-19. The trial, who’s top-line data is expected in one month, has...
The U.S. Food and Drug Administration (FDA) has made their REMS requirements for transmucosal immediate-release fentanyl (TIRF) products more rigorous to minimize inappropriate prescriptions for the strong and highly addictive opioid. The REMS guidelines serve as a...
The Chinese company InnoCare Pharma announced today (12/28) that its BTK inhibitor orelabrutinib received approval for the treatment of cancer and autoimmune diseases, specifically relapsed/refractory chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma...
The Department of Justice sued Walmart yesterday (12/22) for inadequately screening for questionable prescriptions, ultimately fueling the nation’s opioid crisis. According to the lawsuit, Walmart’s understaffed pharmacies pressured employees to fill prescriptions...
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