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.
Boehringer and Eli Lilly announced full results from the EMPERIAL-Reduced and EMPERIAL-Preserved trials related to exercise ability and symptom improvement with Jardiance (empagliflozin) in adults with chronic heart… 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.
In March 2020, the RECOVERY (Randomised Evaluation of COVid-19 thERapY) trial was established as a randomised clinical trial to test a range of potential treatments for COVID-19, including… 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.
Recordati announces positive results from the large Phase III LINC-4 study of Isturisa (osilodrostat) for the treatment of patients with Cushing’s disease for whom pituitary surgery is not… read more.
Merck Inc and Pfizer announced the presentation of results from the Phase III VERTIS CV cardiovascular (CV) outcomes trial that evaluated Steglatro (ertugliflozin), an oral sodium-glucose cotransporter 2… read more.
The FDA has approved Lyumjev (insulin lispro-aabc injection, 100 units/mL and 200 units/mL), Eli Lilly and Company’s new rapid-acting insulin indicated to improve glycemic control in adults with… read more.
Novartis, announced that the FDA has approved Cosentyx (secukinumab) for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA), confirming Cosentyx efficacy in addressing the axial spondyloarthritis (axSpA) disease… read more.
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