26 January 2021 - FDA grants priority review of the application and sets a PDUFA target action date of 8 June ...
29 December 2020 - Eyenovia today announced that it has submitted a new drug application to the U. S. FDA ...
21 December 2020 - More than 600 people with certain rare cystic fibrosis mutations are now eligible for Trikafta, Symdeko or ...
13 November 2020 - Heron Therapeutics today announced that the new drug application was resubmitted to the U.S. FDA for HTX-011, ...
22 October 2020 - U.S. Prescribing Information updated to include PSO-LONG clinical trial data concerning long-term use (52 weeks) of twice-weekly ...
1 September 2020 - More than 600 people with certain rare cystic fibrosis mutations could become newly eligible for Trikafta, Symdeko ...
August 2020 - ViiV Healthcare today announced that the US FDA approved Dovato (dolutegravir/lamivudine) as a complete regimen for the treatment ...
24 July 2020 - Approval based on Phase III ETHOS trial which showed a statistically significant reduction in the rate of ...
22 July 2020 - MC2 Therapeutics announced today that the U.S. FDA has approved Wynzora (calcipotriene and betamethasone dipropionate, w/w ...
7 July 2020 - Today, the Food and Drug Administration approved an oral combination of decitabine and cedazuridine (Inqovi, Astex ...
29 June 2020 - Complete response letter requests additional non-clinical information. ...
24 June 2020 - Mayne Pharma is pleased to announce the new drug application for E4/DRSP to prevent pregnancy has been ...
4 June 2020 - Today, the U.S. Food and Drug Administration approved Recarbrio (a combination of imipenem-cilastatin and relebactam) to treat ...
2 June 2020 - Helsinn today announces that the U.S. FDA has approved the ready-to-dilute liquid formulation of Akynzeo (fosnetupitant/palonosetron) ...
1 June 2020 - Sumitovant Biopharma announced today that Myovant Sciences has submitted a new drug application to the U.S. FDA ...