Myovant Sciences announced that its New Drug Application (NDA) for once-daily, oral relugolix (120 mg) for the treatment of men with advanced prostate cancer has been accepted for… read more.
Merck Inc announced results from two initial Phase III studies evaluating the safety, tolerability and immunogenicity of V 114, the company’s investigational 15-valent pneumococcal conjugate vaccine for pneumococcal… read more.
Epizyme, Inc. announced that the FDA has approved the supplemental New Drug Application (sNDA) for Tazverik (tazemetostat) for the following two distinct follicular lymphoma (FL) indications:1. Adult patients… read more.
Finch Therapeutics Group, Inc. announced positive topline results from PRISM3, its multi-center, randomized, double-blind, placebo-controlled Phase II trial of CP 101 , an investigational oral microbiome drug, for… read more.
Nabriva Therapeutics has received a Complete Response Letter from the FDA for the New Drug Application (NDA) resubmission seeking marketing approval of Contepo (fosfomycin) for injection for the… read more.
Ridgeback Biotherapeutics announces the launch of two Phase II clinical trials to test the efficacy of EIDD 2801 as an anti-viral treatment for COVID-19. Phase I trials recently… read more.
Genentech/Roche announced that the Phase III IPATential150 study with RG 7440 (ipatasertib) plus Zytiga (abiraterone) plus prednisone met its co-primary endpoint of radiographic progression-free survival (rPFS) in patients… read more.
BeiGene, Ltd. announced that its marketing authorization application (MAA) for Brukinsa (zanubrutinib) for the treatment of patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior… read more.
Akili has announced that the FDA has granted clearance for EndeavorRx (AKL-T01) as a prescription treatment for children with attention-deficit/hyperactivity disorder (ADHD). Delivered through a captivating video game… read more.
Merck Inc., announced that the FDA has approved Keytruda, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational… read more.
Ultragenyx Pharmaceutical Inc.and Kyowa Kirin Co., Ltd. announced that the FDA has approved Crysvita (burosumab) for the treatment of fibroblast growth factor 23 (FGF23)-related hypophosphatemia in tumor-induced osteomalacia… read more.
BioMarin Pharmaceutical Inc. announced additional data from its previously reported four-year update of an open-label Phase 1/II study of valoctocogene roxaparvovec , an investigational gene therapy treatment for… read more.
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