News | January 12, 2022
Veristat supported marketing applications for 12 % of all FDA Novel Drug Approvals in 2021
This surpasses the number of approvals supported in 2020
This surpasses the number of approvals supported in 2020
CuraTeQ and Orion had entered into a licensing agreement, granting marketing and distribution rights for CuraTeQ’s biosimilar products under development in the Nordic states, Austria, Hungary and Slovenia
All the recommendations have been sent to the Drugs Controller General of India (DCGI) for final approval.
Application based on DESTINY-Breast03 results showing Daiichi Sankyo and AstraZeneca’s trastuzumab deruxtecan reduced risk of disease progression or death by 72% versus trastuzumab emtansine (T-DM1)
The medicine is the first and only oral MET inhibitor to receive CHMP positive opinion in Europe for adult patients with advanced NSCLC harbouring alterations leading to METex14 skipping
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
Intox is a GLP certified pre-clinical contract research organization with its test facilities in Pune
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)
Applications supported by positive results from the pivotal Phase 3 POETYK-PSO clinical trial program demonstrating superior efficacy of deucravacitinib over Otezla (apremilast)
The European Commission (EC) granted marketing authorisation for Celltrion’s regdanvimab following a positive opinion by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) last week
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