Approval based on DESTINY-Lung02 results where AstraZeneca and Daiichi Sankyo’s Enhertu demonstrated a confirmed objective response rate of 49% and median duration of response of 16.8 months in previously treated patients
The sBLA is supported by a usability study which confirmed that individuals over 18 years of age could self-administer
The Responsible Export Organisation (REO) certification is a distinguished recognition awarded by the Confederation of Indian Industry (CII)
Additional premium services in RegXcellence will include access to BASF’s Product Carbon Footprint data and direct downloads of audit reports
Nanoform will receive access to compound libraries and large data sets to undertake STARMAP screening
The company is confident of addressing all the observations within the stipulated time
Animations, colors, and shapes help to improve poor situational awareness, which is responsible for 81.5% of anesthesia-related errors
Astria will assume full cost and responsibility for the global development and commercialization of the licensed therapeutic program for all indications
Clinical Trial Data Services supports small to midsize sponsor companies helping them to take the next step towards market approval for their drug or device product.
Glenmark will receive from Cassiopea, a subsidiary of Cosmo, the exclusive right to commercialize Winlevi in 15 EU countries
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