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
Five potential first-in-class assets aimed at delivering significant long-term growth. Over 14 clinical development programs underway across portfolio and 11 new studies to start in 2022 across early- and late-stage pipeline
Achondroplasia is a genetic condition that causes severely short stature and disproportionate growth
It is anticipated to be safe and efficacious by targeting the receptor-binding domain (RBD) of the new coronavirus
The Drug Controller General of India (DCGI), is reviewing clinical data of molnupiravir for the treatment of Covid-19 in adults in India
Covaxin is the only Covid-19 vaccine to have demonstrated efficacy data from phase III clinical trials against the Delta variant at 65.2%
The submission is based on Phase 2/3 study of mRNA-1273 in children ages 6 to 11
Positive results reinforce the improved efficacy seen with Opdivo-based treatments in four Phase 3 clinical trials in earlier-stage cancers, including lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer and melanoma
Applications remain under review by others including U.S. Food and Drug Administration and the European Medicines Agency
All modules required for regulatory review of Novavax vaccine, including CMC data, are now complete for WHO
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