Kymriah, the first-ever FDA-approved CAR-T cell therapy, is currently available in 30 countries in one or more indications
A growing number of studies have shown the benefit of a third dose of Covid-19 vaccine in immunocompromised subjects
The company claims to be a market leader in core orthopaedic and gynaecology segments like bone and joint disorders, pain management and, pregnancy and women’s nutrition
The BLA is being submitted under the accelerated approval pathway and is primarily based on clinical, biomarker and safety data from the Phase 2b clinical trial in people with early AD and confirmed amyloid pathology
The product can be used by any lab that conducts NGS testing, making precision medicine accessible to all cancer patients
It is designed to tackle mental health issues
Earlier, the USFDA has granted ‘Orphan Drug Designation’ and ‘Fast Track Designation’ to Saroglitazar Mg for PBC
US revenues were sequentially stable at US$370mn with steady performance in the specialty portfolio
Dr. Sharvil Patel cites the example of prescriptions being handed over to patients despite unavailability of enough stock of such medicines
The company received one observation in the Form-483
Subscribe To Our Newsletter & Stay Updated
