accelerated approval
FDA grants accelerated approval for new oral treatment for Fabry disease
The US Food and Drug Administration (FDA) has granted accelerated approval for a new treatment for adults with Fabry disease — a rare genetic disorder, resulting from the build-up of globotriaoscylceramide (GL-3) in blood vessels and organs. more
FDA grants accelerated approval to Amgen’s MRD-positive ALL treatment
The US FDA has granted accelerated approval to Amgen’s Blincyto (blinatumomab) to treat adults and children with B-cell precursor acute lymphoblastic leukaemia who are in remission but still have minimal residual disease (MRD) more
Drug price wars! FDA to be more involved in pricing, according to reports
The Food and Drug Administration (FDA), under new commissioner Scott Gottlieb, will be taking more of an active role in the issues surrounding drug prices, according to various US news sources. more
FDA approves skin cancer treatment
The FDA has granted accelerated approval to Bavencio (avelumab) for the treatment of adults and paediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC), including those who have not received prior chemotherapy. more
Bladder cancer medication receives accelerated approval from FDA
The US Food and Drug Administration (FDA) have granted accelerated approval to Genentech’s medication to treat people with bladder cancer more
