Zogenix, Inc. announced that the FDA has approved Fintepla (fenfluramine) oral solution, CIV for the treatment of seizures associated with Dravet syndrome in patients 2 years of age… read more.
Fulcrum Therapeutics, Inc. announced that it received early notification from the FDA that the company may proceed with initiating a Phase III, randomized, double-blind, placebo-controlled trial of losmapimod… read more.
Merck announced that the FDA has approved Keytruda, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that… read more.
Full results from the positive Phase III ETHOS trial showed AstraZeneca’s triple-combination therapy Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate) demonstrated a statistically significant reduction in the rate of moderate or… read more.
Gencurix has received FDA Emergency Use Authorization for its GenePro SARS-CoV-2 Test. It is the second RT-PCR test that Gencurix has launched following the first test assay, GenePro… read more.
Principia Biopharma Inc. announced that the first patient has been enrolled in its partner Sanofi’s Phase III clinical trial of SAR 442168 in patients with relapsing multiple sclerosis… 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.
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.
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.
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.
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.
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