Bristol Myers Squibb (NYSE: BMY) has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Opdivo® (nivolumab) combined with cisplatin and gemcitabine as the first-line treatment for…
Voydeya (danicopan) Receives EU Approval as Supplemental Treatment for Adults with PNH and Residual Hemolytic Anemia Voydeya (danicopan) has gained approval in the European Union (EU) to be used alongside ravulizumab or eculizumab for managing adult patients with paroxysmal nocturnal…
Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) has announced that the U.S. Food and Drug Administration (FDA) has given approval for Alecensa® (alectinib), an anaplastic lymphoma kinase (ALK) inhibitor, to be used as an adjuvant treatment subsequent to tumor resection for…
Viatris, a leading global healthcare company, has announced the appointment of Corinne Le Goff as its Chief Commercial Officer, effective immediately. Le Goff brings over 25 years of experience in the biotechnology and pharmaceutical sectors, having successfully led and nurtured…
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235) has received FDA approval for TEVIMBRA® (tislelizumab-jsgr) as a monotherapy for adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) who have undergone prior systemic chemotherapy not including a PD-(L)1…
Revance Therapeutics, Inc. (NASDAQ: RVNC) has unveiled significant insights into DAXXIFY® for the treatment of cervical dystonia at the American Academy of Neurology (AAN) annual meeting, running from April 13-18, 2024, in Denver, Colorado. The presentations, ASPEN-1 and ASPEN-OLS (open…
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,…