Biocon Biologics receives MHRA, UK Approval for Biosimilar Aflibercept ‘Yesafili’

Yesafili, received marketing authorization approval from the European Commission for the European Union

ImmunoACT announces the approval of India's first CAR-T cell therapy 'NexCAR19'

NexCAR19 is an indigenously developed CD19 targeted CAR-T cell therapy

Cosmo and Glenmark sign distribution and license agreements for Winlevi in Europe and South Africa

Glenmark will receive from Cassiopea, a subsidiary of Cosmo, the exclusive right to commercialize Winlevi in 15 EU countries

Biocon Biologics receives European Commission approval for biosimilar of Aflibercept ‘Yesafili’

The centralized marketing authorization granted by the EC is valid in all EU Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway

Merck receives positive EU CHMP opinion for Keytruda as adjuvant treatment for cell lung cancer

Opinion granted based on positive disease-free survival results from the Phase 3 KEYNOTE-091 trial

Shilpa Medicare receives UK MHRA approval for mouth-dissolving strips to treat illnesses

This approval has come from the company's finished dosage form manufacturing facility

Pfizer and BioNTech receive positive CHMP opinion for Omicron XBB.1.5-adapted COVID-19 vaccine

The updated COVID-19 vaccine is tailored to the Omicron XBB.1.5 sublineage of SARS-CoV-2 and is recommended for individuals 6 months of age and older

EMA accepts LEO Pharma’s MAA for delgocitinib cream in chronic hand eczema

LEO Pharma is developing delgocitinib cream for the treatment of moderate to severe chronic hand eczema, a hard-to-treat disease where there is a high unmet medical need for treatment

Hikal receives Brazilian GMP certification and USFDA EIR for Bangalore and Panoli facilities

USFDA approves Merck’s ERVEBO for use in children 12 months of age and older

Merck continues progress in helping to protect people at risk of Zaire ebolavirus disease