Acquisition will add GT005 to the Novartis portfolio, an investigational, one-time gene therapy currently in Phase 2 for the treatment of people living with Geographic atrophy
The NMPA approval is based on the positive data of GEMSTONE-302 study, a multi-center, randomized, double-blind, phase III study that evaluated the efficacy and safety of Cejemly or placebo in combination with chemotherapy in first-line stage IV NSCLC patients
The company will collaborate with U.S.-based colleagues to help life sciences companies improve commercial effectiveness
First Emergency Use Listing granted by WHO for a protein-based Covid-19 vaccine
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
The data has been shared with the U.S.FDA as part of an ongoing rolling submission for Emergency Use Authorisation
Immatics to receive upfront payment of US $ 150 million and additional milestone payments of up to US $ 770 million plus tiered double-digit royalties on net product sales
FDA changes inspection classification of the facility to Voluntary Action Indicated
The group now has 325 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04.
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)
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