Biocon Biologics gets EMA’s positive opinion for an ophthalmology product

Merck receives positive European Union CHMP opinion for Gefapixant

The CHMP’s recommendation will now be reviewed by the European Commission for marketing authorization in the European Union

Merck receives positive EU CHMP opinion for pembrolizumab plus Trastuzumab and Chemotherapy as first-line treatment for HER2-positive advanced gastric or gastroesophageal junction

If approved, KEYTRUDA would be the first immunotherapy for the first-line treatment of HER2-positive advanced gastric or GEJ cancer in tumors expressing PD-L1 (CPS ?1) in the EU

Moderna announces regulatory submissions for its RSV vaccine

The company has submitted marketing authorization applications for mRNA-1345 with the European Medicines Agency (EMA), Swissmedic in Switzerland, and the Therapeutic Goods Administration (TGA) in Australia

Novavax's Nuvaxovid receives full marketing authorization in the EU

Marketing Authorization replaces conditional Marketing Authorization and is first for Novavax in the EU

Wacker Biotech partners with Caeregen Therapeutics on regenerative treatment for vision loss

As Caeregen’s CDMO partner for CTR-107, Wacker Biotech will produce drug substance at its site in Halle, Germany, and complete clinical trial drug product production at its site in Amsterdam, the Netherlands

Aurobindo's subsidiary to withdraw application for EU marketing authorization of two biosimilars

This request for withdrawal of the two dossiers was made after necessary consultations and receiving guidance from EMA

Venus Remedies receives Ukrainian GMP approval for Its Carbapenem, Oncology parenteral facilities

The company expects this approval in Baddi to pave the way for GMP certifications from European Medicines Agency and other PIC/S member nations

European Commission authorises GSK’s Arexvy for older adults

Authorisation will help protect adults 60 years of age and older in 30 European countries* from RSV disease for the first time

USFDA approves GSK’s respiratory syncytial virus vaccine ‘Arexvy’

Ground-breaking approval enables adults aged 60 years and older to be protected from RSV disease for the first time