European Commission Grants Approval to Moderna’s RSV Vaccine, mRESVIA
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 and BioNTech Get U.S. FDA Approval for Omicron KP.2-Adapted COVID-19 Vaccine
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…
China Approves PADCEV™ for Advanced Urothelial Cancer
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…
TEPKINLY® (epcoritamab) Gets Second European Approval for Relapsed/Refractory Follicular Lymphoma
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 Appoints New Leaders in R&D and Business Development
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 Announces Strong Interim Results for 2024
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 Unveils Late-Breaking Abstract on Cenerimod at the 26th APLAR Annual Congress
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 Updates on Phase 3 Trial of Cannabidiol for Epilepsy in Japan
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 to Expand Production Capabilities at Kansas Manufacturing Facility
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 Gains Health Canada Approval for Pegfilgrastim Biosimilar
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…
Bristol Myers Squibb’s sBLA Accepted by FDA for First-Line Treatment of Unresectable Hepatocellular Carcinoma
Bristol Myers Squibb (NYSE: BMY) announced today that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Opdivo® (nivolumab) in combination with Yervoy®…
OTEZLA® (Apremilast) Now Available in the U.S. for Moderate to Severe Pediatric Plaque Psoriasis Treatment
Amgen (NASDAQ: AMGN) has announced that Otezla® (apremilast) is now available in the U.S. for pediatric use. Earlier this year, the U.S. Food and Drug Administration (FDA) approved Otezla for…