Drug Approval | June 23, 2022
Menarini Group and Radius Health submit new drug application to the USFDA for Elacestrant
Intended for potential treatment of ER+/HER2- advanced or metastatic breast cancer patients
Intended for potential treatment of ER+/HER2- advanced or metastatic breast cancer patients
If approved, ABBV-951 will offer patients the first continuous subcutaneous delivery of carbidopa/levodopa prodrugs
If granted, Nuvaxovid would be the first protein-based Covid-19 vaccine option for adolescents in Australia and New Zealand
The companies expect to complete the submission of the NDA for treatment of MDD in the second half of 2022; associated filing for postpartum depression is anticipated in the first half of 2023
Covaxin is a whole-virion inactivated Covid-19 investigational vaccine candidate that uses the same vero cell manufacturing platform that has been used in the production of polio vaccines for decades
Nirsevimab is the first investigational long-acting antibody designed to protect all infants for the respiratory syncytial virus season with a single dose
On track to complete the BLA submission in the first half of 2022
Emergency Use Authorisation application request to be submitted following one month required by FDA EUA guidance
Trastuzumab is monoclonal antibody used to treat human epidermal growth factor receptor 2 positive (HER2+) breast cancer and metastatic gastric cancers
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In Japan, breast cancer is the most common cancer in women, with approximately 92,000 cases of breast cancer diagnosed in 2020
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