Green light for six new medicines in the EU
The European Medicines Agency (EMA) has given its approval for six new medicines, with another nine products receiving extensions for their therapeutic indications. The decisions came as the… read more.
The European Medicines Agency (EMA) has given its approval for six new medicines, with another nine products receiving extensions for their therapeutic indications. The decisions came as the… read more.
Gilead Sciences Inc. announced Trodelvy (sacituzumab govitecan-hziy) has now been added to the NCCN Guidelines as a category 1 preferred first-line treatment option for people with metastatic triple-negative… read more.
Bayer announced that the CHMP of the EMA has adopted a positive opinion recommending finerenone (Kerendia), a non-steroidal, selective mineralocorticoid receptor antagonist (nsMRA), for the treatment of adults… read more.
Fortress Biotech, Inc. announced that the U.S. Food and Drug Administration has approved ZYCUBO (copper histidinate, formerly known as CUTX-101) for the treatment of Menkes disease in pediatric… read more.
GSK plc announced that its adjuvanted recombinant respiratory syncytial virus (RSV) vaccine, Arexvy, has been approved by the European Commission (EC) for use in adults aged 18 years… read more.
Medtronic announced significant U.S. milestones that expand access, choice, and flexibility for people living with type 1 and insulin‑requiring type 2 diabetes. These milestones include FDA clearance for… read more.
TG Therapeutics, Inc. announced the upcoming schedule of presentations highlighting Briumvi (ublituximab-xiiy), to be presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) annual forum,… read more.
Intuitive, a global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery, announced that the FDA has cleared the da Vinci 5 system for certain… read more.
Johnson & Johnson announced a new analysis of Phase III data which found Caplyta (lumateperone), in combination with an antidepressant, showed significantly greater remission rates in adults with… read more.
Idorsia Ltd announces that the results of lucerastat treatment over 42-months and the kidney biopsy data will be presented at the 22nd Annual WORLDSymposium taking place from February 2-6, 2026…. read more.
Soleno Therapeutics Inc. announced a publication in the peer-reviewed Journal of Clinical Endocrinology and Metabolism (JCEM). The paper, titled, “Diazoxide Choline Extended-Release Tablets in Prader-Willi Syndrome: A Randomized,… read more.
NICE (UK) is unable to make a recommendation on concizumab (Alhemo) for treating haemophilia A or B in people 12 years and over with factor inhibitors. This is… read more.