Bristol Myers Squibb and bluebird bio, Inc. announced that the companies received a Refusal to File letter from the FDA regarding the Biologics License Application (BLA) for idecabtagene… read more.
Vanda Pharmaceuticals Inc. announced that following the completion of a Type A Meeting with the FDA on 8 May 2020, it has reached agreement with the FDA to… read more.
Gamida Cell Ltd.:announced positive topline results from its Phase III clinical study evaluating the safety and efficacy of omidubicel, an investigational advanced cell therapy in development as a… read more.
Bristol Myers Squibb announced three-year follow-up results from Part 1 of the Phase III CheckMate -227 trial , demonstrating that Opdivo (nivolumab) plus Yervoy (ipilimumab) provided sustained improvements… read more.
Bristol Myers Squibb announced the first presentation of results from the Phase III CheckMate -9LA trial, which demonstrated a statistically significant and clinically meaningful survival benefit with Opdivo… read more.
Health Canada says it has authorized the first COVID-19 serological test for use in the country to detect antibodies specific to the virus. DiaSorin, an Italian multinational biotechnology… read more.
A randomized, controlled clinical trial evaluating the safety and efficacy of a treatment regimen of the investigational antiviral remdesivir plus the anti-inflammatory drug baricitinib for coronavirus disease 2019… read more.
The Phase III IKEMA clinical trial evaluating Sarclisa (isatuximab) added to carfilzomib and dexamethasone met the primary endpoint at its first planned interim analysis, demonstrating significantly prolonged progression-free… read more.
MyoKardia announced positive topline data from the company’s Phase III pivotal EXPLORER-HCM clinical trial of MYK 461 (mavacamten) for the treatment of patients with symptomatic, obstructive hypertrophic cardiomyopathy… read more.
Abbott announced that the FDA issued Emergency Use Authorization (EUA) for the company’s SARS-CoV-2 IgG lab-based serology blood test on the Alinity i system. Abbott plans to ship… read more.
Protalix BioTherapeutics announced positive topline results from its Phase III BRIDGE clinical trial of PRX 102 (pegunigalsidase alfa), the Company’s plant cell-expressed recombinant, PEGylated, cross-linked alpha-galactosidase-A product candidate… read more.
Genfit announced results from an interim analysis of the RESOLVE-IT Phase III trial evaluating once-daily, 120mg of elafibranor in adults with non-alcoholic steatohepatitis (NASH). The trial did not… read more.
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