GSK plc (LSE/NYSE: GSK) has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to GSK5764227 (GSK’227), an investigational B7-H3-targeted antibody-drug conjugate (ADC) being studied…
Eisai Co., Ltd. (Tokyo, CEO: Haruo Naito) and Biogen Inc. (Cambridge, Massachusetts, CEO: Christopher A. Viehbacher) have announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain…
Moderna, Inc. (NASDAQ) has announced that the European Commission (EC) has granted marketing authorization for mRESVIA® (mRNA-1345), an mRNA vaccine designed to protect adults aged 60 and older from lower…
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) have announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application for their COMIRNATY® COVID-19…
Astellas Pharma Inc. (TSE: 4503), led by President and CEO Naoki Okamura, has announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted…
Genmab A/S (Nasdaq: GMAB) has announced that the European Commission (EC) has granted conditional marketing authorization for TEPKINLY® (epcoritamab) as a monotherapy for adult patients with relapsed or refractory (R/R)…
BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) has announced key leadership changes in its research and development and business development teams. Effective September 30, Greg Friberg, M.D., will join the company as…
WuXi Biologics (Cayman) Inc. (“WuXi Biologics” or “the Group”, stock code: 2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO) providing comprehensive solutions for biologics discovery, development, and…
Viatris Inc. (NASDAQ: VTRS), a leading global healthcare company, today presented results from its Phase 2 study of cenerimod (ACT-333441) as a late-breaking abstract at the 26th Asia-Pacific League of…
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) has announced the top-line results from a Phase 3 open-label, single-arm trial conducted in Japan. The study assessed the safety and efficacy of their cannabidiol…
Elanco Animal Health Incorporated (NYSE: ELAN) has announced a significant expansion of its biologics manufacturing facility in Elwood, Kansas. The 25,000-square-foot expansion represents a $130 million investment that will be…
Lupin Limited, a leading global pharmaceutical company, has announced that it has received approval from Health Canada for its biosimilar Pegfilgrastim. The product, to be marketed under the brand name…