The China’s National Medical Products Administration (NMPA) has granted marketing authorisation to Sichuan Kelun-Biotech Biopharmaceutical’s sacituzumab tirumotecan (sac-TMT), a domestically developed trophoblast cell surface antigen 2 (TROP-2)-directed antibody-drug conjugate (ADC) for the treatment of the adult population with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC).
Johnson & Johnson (J&J) will resume Covid-19 vaccine roll-out in Europe following the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC), which confirmed the overall benefit-risk profile being positive.
GlaxoSmithKline and Vir Biotechnology have announced the European Medicines Agency (EMA) review of VIR-7831 (GSK4182136) for the early treatment of Covid-19.
Integrated pharmaceutical company Dr. Reddy’s Laboratories has secured Emergency Use Authorisation (EUA) from the Drug Controller General of India (DCGI) to import Russia’s Sputnik V vaccine into India.
The European Medicines Agency (EMA) has validated Gilead Sciences’ marketing authorization application (MAA) for sacituzumab govitecan-hziy (SG) to treat advanced breast cancer.
Biopharmaceutical company Dynavax Technologies (DVAX) has secured marketing authorisation from the European Commission (EC) for Heplisav B, a two-dose adult hepatitis B adjuvanted vaccine.
South Korean biopharmaceutical company Celltrion Healthcare has secured European Commission (EC) marketing authorisation for the sale of Yuflyma (CT-P17) for the treatment of multiple chronic inflammatory diseases.
Bristol Myers Squibb announced that the European Commission (EC) has approved Opdivo (nivolumab) plus Yervoy (ipilimumab) with two cycles of platinum-based chemotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation.
GlaxoSmithKline (GSK) announced the European Commission has approved Zejula (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor, as first-line monotherapy maintenance treatment for adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response following platinum-based chemotherapy.
AstraZeneca’s Imfinzi (durvalumab) has been approved in the European Union for the 1st-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) in combination with a choice of chemotherapies, etoposide plus either carboplatin or cisplatin.
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