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

EMA’s CHMP recommends authorization of Moderna's Covid-19 vaccine Spikevax for SARS-CoV-2 Variant LP.8.1

Moderna's updated COVID-19 mRNA vaccine will be available for the 2025-2026 vaccination season, pending a European Commission authorization decision

Bayer’s Nubeqa receives EU approval for patients with advanced prostate cancer

European Commission granted approval of darolutamide in combination with androgen deprivation therapy (ADT) for patients with metastatic hormone-sensitive prostate cancer (mHSPC)

Concord Biotech announces successful completion EU GMP inspection at its API facility

This achievement underscores our unwavering commitment to upholding the highest standards of quality, safety, and regulatory compliance

Valneva lifts EMA’s temporary restriction on use of chikungunya vaccine IXCHIQ in elderly

The agency concluded that for people of all ages, IXCHI should be administered when there is a significant risk of chikungunya infection

FDA approves Bravecto Quantum from Merck Animal Health

Novo Nordisk submits application to EMA for higher dose of Wegovy for obesity treatment

The submission is based on data from the STEP UP and STEP UP T2D clinical trials

EMA and HMA to strengthen Anti-D Immunoglobulin supply chain

These medicines are essential in preventing RhD immunisation during pregnancy

Biocon Biologics receives MHRA UK approval for Vevzuo and Evfraxy, Denosumab Biosimilars

Vevzuo is authorized for the prevention of skeletal related events in adults with advanced malignancies involving bone

Imfinzi approved in the EU as first and only perioperative immunotherapy for muscle-invasive bladder cancer

Approval based on NIAGARA Phase III trial results which showed a 32% reduction in the risk of recurrence and a 25% reduction in the risk of death for the Imfinzi regimen vs. neoadjuvant chemotherapy alone