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

FDA approves sBLA for Takeda's Vonvendi for Von Willebrand disease

Vonvendi is the only recombinant Von Willebrand factor replacement therapy with approved indications in adults and children with VWD

CuraTeQ Biologics receives approval for biosimilar Dazublys from UK's MHRA

Earlier in July 2025, Dazublys has received the marketing authorisation in the European Union from the European Commission

Bristol Myers Squibb to present new cardiovascular data at ESC Congress 2025

Enanta files patent infringement suit against Pfizer

The ‘265 Patent is based on Enanta’s July 2020 patent application describing coronavirus protease inhibitors invented by Enanta scientists

European Commission grants approval of Ogsiveo

OGSIVEO is the first and only therapy to receive marketing authorization in the EU for the treatment of desmoid tumors

Lupin partners with Sadoz to commercialise Ranibizumab biosimilar

Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that binds to and inhibits vascular endothelial growth factor A

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