Harmony Biosciences announced that the FDA has approved its supplemental New Drug Application (sNDA) for Wakix (pitolisant) tablets for the treatment of excessive daytime sleepiness (EDS) in pediatric… read more.
Novo Nordisk’s weight-loss drug Wegovy has been approved for sale in China, opening the door to a huge market in which obesity rates have more than doubled among… read more.
Johnson & Johnson MedTech unveiled Polyphonic, the open and secure digital ecosystem for a more connected surgical experience. The ecosystem features software applications that are agnostic to data… read more.
UCB, announced the first presentation of two-year data from the Phase III studies, BE MOBILE 1 and BE MOBILE 2, and the open-label extension, BE MOVING, evaluating bimekizumab,… read more.
AstraZeneca’s Farxiga (dapagliflozin) has been approved by the FDA to improve glycaemic control in paediatric patients with type-2 diabetes (T2D) aged 10 years and older. The FDA approval… read more.
Eisai Co. Ltd. and Biogen Inc. announced that that the FDA has accepted Eisai’s Supplemental Biologics License Application (sBLA) for monthly lecanemab-irmb (U.S. brand name: Leqembi) intravenous (IV)… read more.
Aurinia Pharmaceuticals Inc. announced an oral presentation at the European Alliance of Associations for Rheumatology (EULA R) 2024 taking place in Vienna, Austria June 12-15. The data reinforces… read more.
Ipsen announced that the FDA has granted accelerated approval for Iqirvo (elafibranor) 80 mg tablets for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid… read more.
Bristol Myers Squibb announced that the European Commission (EC) has approved Opdivo (nivolumab) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable… read more.
GSK plc announced that the FDA has approved Arexvy (Respiratory Syncytial Virus (RSV) Vaccine, Adjuvanted) for the prevention of RSV lower respiratory tract disease (LRTD) in adults 50… read more.
Almirall, announced that the FDA has approved Almirall’s recent supplemental New Drug Application (sNDA) to expand the use area for its drug, Klisyri, to up to 100 cm…. read more.
Outlook Therapeutics, Inc., a biopharmaceutical company focused on the commercialization and development of ONs-5010/Lytenava (bevacizumab-vikg; bevacizumab gamma), for the treatment of retina diseases, announced that the European Commission… read more.
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