OR WAIT null SECS
September 02, 2020
The agency is reviewing an application for Dexamethasone Taw for treating adult patients with COVID-19.
August 20, 2020
BioMarin received the complete response letter for valoctocogene roxaparvovec, its gene therapy intended for treating severe hemophilia A.
A new FDA guidance provides answers to questions about when the agency will seek to visit a site during the COVID-19 pandemic and how it will respond when a needed inspection cannot be conducted safely.
August 18, 2020
The agency describes the requirements for retaining reserve samples of test articles and reference standards used in an in-vivo bioavailability and in-vivo or in-vitro bioequivalence study.
FDA published guidance regarding the development of treatments for acute myeloid leukemia.
August 14, 2020
The agency provides recommendations for development and labeling of drugs to treat male patients with breast cancer.
August 13, 2020
The company has launched its biosimilar rituximab, Ritucad, for the Indian market.
FDA has approved Evrysdi (risdiplam) for treating spinal muscular atrophy in adults and children.
The companies received approval from the EC for Zercepac (HLX02), a biosimilar referencing Roche’s originator biologic, Herceptin (trastuzumab).
Veklury (remdesivir) is an investigational antiviral drug that Gilead is developing to treat COVID-19.