Viatris Inc. has been informed that Mapi Pharma Ltd. has received a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for GA Depot 40 mg from the FDA
Vanda Pharmaceuticals Inc. announced that on March 4, 2024, it received a Complete Response Letter (CRL) from the FDA as part of its ongoing review of Vanda's supplemental New Drug Application (sNDA) for Hetlioz (tasimelteon) in the treatment of insomnia characterized by difficulties with sleep initiation
Merck KGaA is dropping its BTK inhibitor evobrutinib several months after a Phase III disappointment. The termination comes as the company moves toward an R&D model driven primarily by licensing deals and optionality
Upsher-Smith Laboratories, Inc., has announced that it has received tentative approval from the FDA for its New Drug Application (NDA)...
After a Refusal to File notification from the FDA for tafamidis from Pfizer, the FDA has now accepted the new...
The FDA has approved a label expansion for ibrutinib (Imbruvica) with an oral suspension formulation for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia, and chronic graft-versus-host disease (cGVHD) after failure on at least 1 line of systemic therapy
Florbetapir PET
Shionogi & Co., Ltd. announced that it has obtained standard approval from the Ministry of Health, Labour and Welfare (MHLW) for Xocova (Generic name: ensitrelvir fumaric acid), a novel anti-SARS-CoV-2 drug for the indication of SARS-CoV-2 infection in Japan
The FDA has approved on 13 March 2013, Lymphoseek (technetium Tc 99m tilmanocept) Injection, from Navidea Biopharmaceuticals , a radioactive...
Mirum Pharmaceuticals, Inc. announced that the FDA has approved Livmarli (maralixibat) oral solution for the treatment of cholestatic pruritus in patients five years of age and older with progressive familial intrahepatic cholestasis (PFIC)