First PARP inhibitor approved in Japan to demonstrate clinically meaningful benefits in combination with a new hormonal agent
The deal represents a total transaction value of up to $36 million with an initial upfront consideration of $14 million
Oteseconazole Capsules were found to be safe and more effective than fluconazole
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
The CHMP’s recommendation will now be reviewed by the European Commission for marketing authorization in the European Union
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
SMPA's diverse portfolio includes six marketed products and a robust pipeline of early- to late-stage assets
Marketing Authorization replaces conditional Marketing Authorization and is first for Novavax in the EU
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
Intent to start at least 5 innovative Phase 3 vaccine programs by 2025
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