Tag Archives: approves

FDA Approves Ontruzant (trastuzumab-dttb), a Biosimilar to Herceptin

Print this page INCHEON, KOREA – January 21, 2019 – Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved Ontruzant (trastuzumab-dttb), a biosimilar referencing Herceptin®i (trastuzumab), across all eligible indications, namely adjuvant treatment of HER2-overexpressing breast cancer, metastatic breast cancer and metastatic gastric cancer or gastroesophageal junction adenocarcinoma… Read More »

FDA Approves ProAir Digihaler (albuterol sulfate) as the First and Only Digital Inhaler with Built-In Sensors

FDA Approves ProAir Digihaler (albuterol sulfate) as the First and Only Digital Inhaler with Built-In Sensors Print this page JERUSALEM–(BUSINESS WIRE)–Dec 21, 2018–Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has approved ProAir ® Digihaler™ (albuterol sulfate 117 mcg) inhalation powder, the first and only… Read More »

FDA Approves Vaxelis Pediatric Hexavalent Combination Vaccine

FDA Approves Vaxelis Pediatric Hexavalent Combination Vaccine Print this page BRIDGEWATER, N.J. and KENILWORTH, N.J. – December 26, 2018 –The U.S. Food and Drug Administration has approved Vaxelis™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine) for use in children from 6… Read More »