Roche has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for updating the European Union (EU) label of Phesgo.
Shanghai Henlius Biotech (Henlius) and Organon have announced the US Food and Drug Administration (FDA) acceptance of the biologic license application (BLA) for HLX14, a biosimilar candidate of PROLIA/XGEVA (denosumab).
The European Medicines Agency (EMA) has validated the marketing authorisation applications (MAAs) for HLX14, an investigational biosimilar to Prolia and Xgeva (denosumab). This announcement was made by Shanghai Henlius Biotech and Organon.
The UK National Institute for Health and Care Excellence (NICE) has recommended GSK’s Dostarlimab, marketed as Jemperli, for use with chemotherapy in treating specific advanced or recurrent womb cancers.
Cosette Pharmaceuticals has acquired the worldwide rights to prescription drug, Intraros, from Endorecherche’s subsidiary Endoceutics.
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