In a major leap for hemophilia patients, Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has granted approval for HYMPAVZI (marstacimab-hncq) to prevent or reduce bleeding episodes in individuals aged 12 and above with hemophilia A or B without inhibitors. This marks a groundbreaking advancement in the treatment landscape for […]
Eton Pharmaceuticals has sent shockwaves through the pharmaceutical industry after its shares soared to a 52-week high, fueled by the acquisition of the critical rare disease treatment Increlex. The stock surged to $6.08, marking a pinnacle in a year filled with strategic moves and bold acquisitions. This dramatic rise in stock value is driven by […]
The European Commission (EC) has granted marketing authorisation for AKANTIOR (polihexanide), the first and only approved treatment for acanthamoeba keratitis (AK) globally, announced Avanzanite Bioscience B.V., a commercial-stage specialty pharmaceutical company. The approval, which applies to both adults and children aged 12 and over, marks a significant milestone for the treatment of this rare and […]
In a significant development for the pharmaceutical industry, Dr. Reddy’s Laboratories Ltd. has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) regarding its proposed biosimilar, DRL_RI, also known as ITUXREDI. This endorsement could pave the way for the launch of this promising biosimilar across European […]
The European Medicines Agency (EMA) has granted approval to Dupixent (dupilumab) as a novel add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by elevated blood eosinophils. This marks the first time Dupixent, jointly developed by Sanofi and Sanofi and Regeneron, is approved for this specific patient group within the European […]
CStone Pharmaceuticals (HKEX: 2616), a leading innovation-driven biopharmaceutical company from China, announced a significant milestone with the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issuing a positive opinion. This recommendation is for the approval of sugemalimab, combined with chemotherapy, as a first-line treatment for metastatic non-small cell lung […]
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a significant boost to Pfizer’s lung cancer drug, Vizimpro (dacomitinib), recommending its approval as a first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). This recommendation specifically targets patients with epidermal growth factor receptor […]