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

Sandoz plans to build a Biosimilar Technical Development Center in Slovenia

Planned investment of approximately USD 90 million to build a state-of-the-art Sandoz Biosimilar Technical Development Center in Ljubljana, Slovenia by 2026

Novartis acquires DTx Pharma to develop siRNA therapies

Deal includes DTx-1252, a potential therapy for the neuromuscular disorder Charcot-Marie-Tooth disease type 1A (CMT1A), and two additional preclinical programs for other neuroscience indications

PrecisionLife identifies first detailed genetic risk factors for long COVID

Long COVID is a debilitating chronic condition that has affected over 100 million people globally

Dupixent is now approved in India for the treatment of adults with moderate-to-severe atopic dermatitis

Sumitomo Pharma America launches as new combined organization

SMPA's diverse portfolio includes six marketed products and a robust pipeline of early- to late-stage assets

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