Organon and Shanghai Henlius Biotech have announced that the European Medicines Agency (EMA) has validated a marketing authorisation application for HLX11, a biosimilar candidate referencing Roche’s ...
On March 5, 2025, the FDA cleared an investigational new drug application for CTD402, a CD7-targeted universal CAR T-cell ...
Dr. Reddy's inks collaboration deal with Bio-Thera to develop and commercialize proposed biosimilar candidates of J&J's Stelara and Simponi in Southeast Asia.
On March 26, 2025, the FDA approved Fresenius Kabi’s denosumab biosimilars, CONEXXENCE® (denosumab-bnht) and BOMYNTRA® (denosumab-bnht), ...
The FDA has approved two new denosumab biosimilars that are interchangeable with the reference medications Prolia and Xgeva, ...
Denosumab-bnht is expected to launch in the US in June 2025 per an agreement with the reference product’s manufacturer, Amgen ...
The fourth pair of denosumab biosimilars, Conexxence and Bomyntra, are expected to launch in the United States in mid 2025, ...
The FDA approved another set of denosumab biosimilars, Conexxence/Bomyntra (denosumab-bnht), expanding treatment options for ...
Newport Healthcare, a national network of evidence-based mental health treatment programs for adolescents and young adults, today announced key findings from its 2024 outcomes report, The Science of ...
LabCentral, the premier Massachusetts-based network of coworking labs designed to accelerate high-potential biotech startups, today announced the release of its 2024 Impact Report. It showcases the ...
Fresenius announced that the Biologics License Application (BLA) for the denosumab biosimilars Conexxence® (denosumab-bnht) and Bomyntra® (denosumab-bnht) of its operating company Fresenius Kabi, has ...
Alvotech will conduct a business update conference call and live webcast on Thursday March 27, 2025, at 8:00 am ET (12:00pm ...
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