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
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
This sBLA submission is supported by clinical, pre-clinical, and manufacturing data demonstrating the safety, tolerability, and immunogenicity of the bivalent vaccine.
Submissions based on favorable MagnetisMM-3 trial results in patients with relapsed or refractory multiple myeloma
This action follows the recent acceptance of the Marketing Authorization Application (MAA) for Pfizer’s RSV vaccine candidate by the European Medicines Agency
CHMP recommendation is based on Phase III data, which demonstrated that darolutamide plus androgen deprivation therapy (ADT) in combination with docetaxel significantly reduced the risk of death by 32.5%
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