December 13, 2024
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorization for Emcitate (tiratricol) for treating peripheral thyrotoxicosis in […]
December 13, 2024
The European Medicines Agency (EMA) has recommended that a new oral agent, Welireg (belzutifan), be granted conditional marketing authorization for treatment of two different diseases: the […]
December 13, 2024
The European Medicines Agency (EMA) has recommended extending the use of Ofev (nintedanib) to include treating progressive fibrosing interstitial lung diseases (ILDs) in children and adolescents […]
December 13, 2024
The European Medicines Agency (EMA) has recommended granting marketing authorization for Seladelpar Gilead (seladelpar lysine dihydrate) to treat primary biliary cholangitis (PBC). PBC is a chronic […]
December 4, 2024
The US Food and Drug Administration (FDA) has granted accelerated approval to zenocutuzumab-zbco (Bizengri, Merus) as an intravenous infusion for the treatment of certain adults with […]
December 3, 2024
The US Food and Drug Administration (FDA) has approved ustekinumab-kfce (Yesintek) as a biosimilar to ustekinumab (Stelara) for the treatment of Crohn’s disease, ulcerative colitis, plaque […]
November 21, 2024
The U.S. Food and Drug Administration (FDA) has approved zanidatamab (Ziihera, Jazz Pharmaceuticals, Inc.) as monotherapy for previously treated, unresectable or metastatic HER2-positive biliary tract cancer […]
November 20, 2024
The US Food and Drug Administration has approved bimekizumab, a humanized interleukin (IL)-17A and IL-17F antagonist, for the treatment of adults with moderate to severe hidradenitis […]
November 15, 2024
Europe’s Committee for Medicinal Products for Human Use (CHMP) has recommended refusal of marketing authorizations for: Cinainu (allium/citrus/Paullinia/cacao), an herbal medicine intended to treat moderate to […]