Sandoz submits Biologics License Application for proposed biosimilar trastuzumab to US FDA
Trastuzumab is monoclonal antibody used to treat human epidermal growth factor receptor 2 positive (HER2+) breast cancer and metastatic gastric cancers
Trastuzumab is monoclonal antibody used to treat human epidermal growth factor receptor 2 positive (HER2+) breast cancer and metastatic gastric cancers
The approval of shelf life extension is based on the availability of additional stability data, which was submitted to the CDSCO
First Emergency Use Listing granted by WHO for a protein-based Covid-19 vaccine
Sputnik Light as a booster significantly increases virus-neutralizing activity against Omicron based on sera 2-3 months after revaccination and is a universal booster to other vaccines inducing stronger antibody and T-cell response
It is the first approved generic and is eligible for 180 days of Competitive Generic Therapy exclusivity
Syngene will also build and operate a new dedicated drug development laboratory to accelerate the advancement of Amgen R&D projects
Deplesin is an add-on therapy to gold standard agents like lithium, valproic acid, and carbamazepine, supporting patients in ways that prescription medications often cannot
While continuing to offer its current breadth of genomic services, Biogazelle will become CellCarta's Center of Excellence for the development of complex genomic biomarker assays
Doctors can now analyse their historical prescriptions within a few clicks enabling them to identify different cohorts of patients and the treatment given to them
FDA changes inspection classification of the facility to Voluntary Action Indicated
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