Ipsen (Euronext: IPN; ADR: IPSEY) has announced the approval by the U.S. Food and Drug Administration (FDA) of the supplemental new drug application for Onivyde® (irinotecan liposome injection) in combination with oxaliplatin, fluorouracil, and leucovorin (NALIRIFOX) as a first-line therapy…
The Hague, April 10, 2024—In a significant milestone for their enduring partnership, the World Health Organization (WHO) and the Netherlands convened to discuss shared priorities and the alignment of strategic goals. This meeting underscored the Netherlands’ steadfast dedication to global…
Today, Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) announced an anticipated booking of approximately ¥70.0 billion in the fourth quarter of fiscal year 2023. This booking pertains to an impairment loss for intangible assets and a…
Bristol Myers Squibb (NYSE: BMY) has disclosed that the European Commission (EC) has broadened the approval of Reblozyl® (luspatercept) to encompass the initial treatment of adult patients grappling with transfusion-dependent anemia linked to very low, low, and intermediate-risk myelodysplastic syndromes…
AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been officially accepted in the United States. This application targets the treatment of adult patients grappling with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC…
WuXi Biologics, a prominent global Contract Research, Development, and Manufacturing Organization (CRDMO), trading as WuXi Bio (2269.HK), proudly announces its sweeping victory at the 2024 CDMO Leadership Awards. The company secured top honors across all six categories – Capabilities, Compatibility,…
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, referred to as “Astellas”) has received notification from the U.S. Food and Drug Administration (FDA) regarding the acceptance of the company’s supplemental New Drug Application (sNDA). This acceptance pertains to…
Bristol Myers Squibb (NYSE: BMY) announced today the unveiling of data at the American College of Cardiology (ACC) Annual Scientific Session & Expo, scheduled for April 6-8, 2024, in Atlanta, Georgia. Roland Chen, MD, Senior Vice President and Head of…
Roche, a leading healthcare company (SIX: RO, ROG; OTCQX: RHHBY), has announced today the approval by the U.S. Food and Drug Administration (FDA) for its cobas® Malaria test, designed for use on the cobas® 6800/8800 Systems. This milestone marks the…
Novo Nordisk has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has provided a positive opinion, recommending the marketing authorization for Awiqli® (the branded name for once-weekly basal insulin icodec) for the treatment of…
AbbVie (NYSE: ABBV) has announced today that the U.S. Food and Drug Administration (FDA) has granted full approval for ELAHERE® (mirvetuximab soravtansine-gynx) for treating folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal adult cancer patients who…
Today, it was announced that Ono has initiated a comprehensive collaboration for drug discovery with the University of Oxford in Oxfordshire, UK. This collaboration aims to explore and validate drug discovery seeds, as well as to obtain screening compounds to…