20 May 2022 - Submission is supported by Phase 3 study that demonstrated patients had significant increases in hours of ...
3 May 2022 - U.S. commercial launch anticipated in the third quarter of 2022. ...
14 April 2022 - Regeneron continues to progress its next generation antibodies, and has initiated a first in human trial. ...
30 March 2022 - The FDA approval of the first dispersible single tablet regimen containing dolutegravir increases age-appropriate treatment options ...
18 March 2022 - Opdualag is a first in class, fixed-dose dual immunotherapy combination treatment of the PD-1 inhibitor nivolumab and ...
15 March 2022 - Agency supports development of complex generic drug-device combination product to improve competition and access to more affordable ...
14 January 2022 - Ryaltris will be marketed and distributed in the United States through its partner Hikma. ...
29 December 2021 - Amylyx Pharmaceuticals today announced that the U.S. FDA has accepted for review its new drug application for ...
13 December 2021 - Commercialisation will start early calendar year 2022. ...
9 December 2021 - Approval provides a significantly broader indication for Zynrelef, now covering approximately 7 million procedures a year. ...
18 October 2021 - FDA approves low dose tablet for HIV treatment in virologically suppressed children weighing at least 14 kg. ...
14 September 2021 - Axsome Therapeutics today announced that the U.S. FDA has accepted for filing the Company’s new drug application ...
12 August 2021 - The U.S. Food and Drug Administration today approved a new indication for Xywav for idiopathic hypersomnia in ...
12 August 2021 - Xywav is the first and only FDA approved treatment for idiopathic hypersomnia. ...
27 July 2021 - Twyneo utilizes Sol-Gel’s proprietary microencapsulation technology and is patent protected until 2038. ...