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)...
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...
Today (12/21) the U.S. Food and Drug Administration (FDA) approved the first oral treatment for prostate cancer, a disease that affects on average one in every nine men. Orgovyx, created by Myovant, was created to treat advanced prostate cancer cases by blocking the...
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