3 March 2021 - The application includes robust data from the Phase 3 registration program, which demonstrated efficacy of daridorexant ...
3 March 2021 - Blueprint Medicines today announced that the EMA has validated the company's type II variation marketing authorisation application ...
3 March 2021 - BLA submitted with FDA’s breakthrough therapy designation. ...
4 March 2021 - Submission supported by data demonstrating Dupixent significantly reduced severe asthma attacks and is the only biologic to ...
4 March 2021 - EMA’s CHMP has started a rolling review of Sputnik V (Gam-COVID-Vac), a COVID-19 vaccine developed by Russia’s ...
2 March 2021 - Recorlev (levoketoconazole) new drug application is supported by previously reported positive and statistically significant results from the ...
3 March 2021 - On Target Laboratories today announced that the U.S. FDA has accepted its new drug application for priority ...
2 March 2021 - Prescription Drug User Fee Act target action date is 17 October 2021. ...
2 March 2021 - Eyenovia today announced that the U.S. FDA has accepted the Company’s new drug application for MydCombi, ...
25 February 2021 - Submission for entering the world’s largest US marketplace. ...
1 March 2021 - Agios Pharmaceuticals today announced that it has submitted a Supplemental new drug application to the U.S. FDA ...
1 March 2021 - Application for orally administered selective P2X3 receptor antagonist based on findings from two Phase 3 trials in ...
1 March 2021 - FT218 assigned PDUFA target action date of 15 October 2021. ...
1 March 2021 - In addition, LFB announces the online publication of the exploratory in vitro study results on eptacog beta ...
26 February 2021 - Incyte today announced the validation of the Company’s marketing authorisation application for retifanlimab, an intravenous PD-1 ...