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August 20, 2020
BioMarin received the complete response letter for valoctocogene roxaparvovec, its gene therapy intended for treating severe hemophilia A.
UK government has set up a new organization to replace Public Health England.
EC finalizes agreement to purchase millions of doses of AstraZeneca's COVID-19 vaccine.
The UK's MHRA will resume on-site risk based GxP inspections from September 2020.
Novavax has signed an agreement with the UK government for 60 million doses of a COVID-19 vaccine and a Phase III clinical trial.
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.
SCA Pharmaceuticals is voluntarily recalling 10 lots of heparin sodium because of the presence of incorrect preservative, benzyl alcohol.
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.