Celltrion plans to provide dual treatment options for COVID-19; Regkirona for hospitalised patients and a nebulised cocktail therapy (CT-P63 in combination with Regkirona) for at- home settings
Adbry is the first biologic launched by LEO Pharma in the United States and is expected to be available in pharmacies by February 2022
The NMPA approval is based on the positive data of GEMSTONE-302 study, a multi-center, randomized, double-blind, phase III study that evaluated the efficacy and safety of Cejemly or placebo in combination with chemotherapy in first-line stage IV NSCLC patients
EMA’s CHMP advice states that Paxlovid can be used for treatment of adults with Covid-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe disease
The data has been shared with the U.S.FDA as part of an ongoing rolling submission for Emergency Use Authorisation
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Primary endpoints and secondary endpoints for which data are available were met in trial dominated by Covid-19 variants
Brii Bio announces amubarvimab/romlusevimab combination received approval from NMPA
Saroglitazar Mg is an investigational compound in the USA, and is yet to be approved by the U.S. Food & Drug Administration (USFDA) or European Medicines Agency (EMA)
Focused medicines company delivering strong operational performance. Building depth in five core therapeutic areas, strength in technology platforms, and a balanced geographic footprint
Applications supported by positive results from the pivotal Phase 3 POETYK-PSO clinical trial program demonstrating superior efficacy of deucravacitinib over Otezla (apremilast)
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