News | July 22, 2023
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
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
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
Decisions on the marketing authorization for Rystiggo in the European and Japanese markets are expected in Q1 of 2024
The booster vaccine can be administered safely to individuals who have received two doses of either Covaxin or Covishield
Sun Pharma will have exclusive rights to commercialise Nidlegy for indications of skin cancers in the territories of Europe, Australia and New Zealand. Philogen will complete pivotal clinical trials for the product in Europe
NDA supported by data from global Phase III FRESCO-2 study in the U.S., Europe, Japan and Australia along with data from Phase III FRESCO study conducted in China
Pre-filled pens containing a combination of insulin glargine 100 Units/mL and lixisenatide for once-daily dosing
The company expects the GMP approval from Saudi Food and Drug Authority (SFDA) to soon pave the way for marketing authorizations from the largest market in the GCC region
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