Obseva announces U.S. FDA acceptance of new drug application for linzagolix
Obseva announced previously that the company has entered into a partnership with Syneos Health to support commercialization of linzagolix in the US and EU
Obseva announced previously that the company has entered into a partnership with Syneos Health to support commercialization of linzagolix in the US and EU
The NDA for Desidustat is based on positive data from the DREAM-ND and DREAM-D Phase 3 trials in patients with Chronic Kidney Disease (CKD) Not on Dialysis and Dialysis
CStone granted the exclusive rights to Hengrui for research, development, registration, manufacturing, and commercialization of anti-CTLA-4 mAb CS1002 in the Greater China region
Achondroplasia is a genetic condition that causes severely short stature and disproportionate growth
Six-months follow-up of prevention trial showed 83% reduced risk of symptomatic Covid-19, with no severe disease or deaths
If approved or authorized, Paxlovid would be the first oral antiviral of its kind, to combat SARS-CoV-2
In the overall study population through Day 28, no deaths were reported in patients who received Paxlovid as compared to 10 deaths in patients who received placebo
Its unique technology, ChetoSensar gives new promise to ADCs by alleviating solubility challenges
The company is continuing with the evaluation of canakinumab in lung cancer, and is applying findings to the overall lung cancer development plan
Following the pre-NDA meeting with the U.S. FDA, the companies confirmed the current efficacy and safety databases are expected to be adequate for filing with confirmed pathways for MDD and PPD
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