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August 31, 2020
Under expanded FDA authorization, Gilead Sciences’ antiviral treatment for COVID-19 can be administered to all hospitalized patients.
August 24, 2020
FDA issued an emergency use authorization for COVID-19 convalescent plasma treatments following a report on NIH concerns about insufficient studies and data.
FDA announced it had issued an emergency use authorization for convalescent plasma that would make it easier to provide this treatment to COVID-19 patients.
August 20, 2020
BioMarin received the complete response letter for valoctocogene roxaparvovec, its gene therapy intended for treating severe hemophilia A.
EC finalizes agreement to purchase millions of doses of AstraZeneca's COVID-19 vaccine.
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.
FDA relies on risk assessments, border inspections, and compliance histories in place of routine audits during the COVID-19 pandemic.
August 14, 2020
The agency provides recommendations for development and labeling of drugs to treat male patients with breast cancer.