US Food and Drug Administration (FDA)

FDA announces $22m for research into products for patients with rare diseases

The US Food and Drug Administration (FDA) has announced research grants of more than $22m to develop products for patients with rare diseases over the next four years.…

Puerto Rico hurricane damage could lead to drug shortages

The damage wreaked by Hurricane Maria in Puerto Rico in September 2017 could have serious repercussions for patients who rely on medicines and healthcare products manufactured there.…

Zika blood test approved by FDA for screening donor blood

A blood test for detecting the Zika virus in donated blood has been approved by US regulators.…

FDA approves first biosimilar for cancer

The US Food and Drug Administration (FDA) has approved a biosimilar of Avastin (bevacizumab) for multiple cancer indications.…

FDA approves first app for substance abuse disorders

The US Food and Drug Administration has approved a mobile app for therapeutic purposes for the first time.…

FDA approves AML drug 17 years after initial approval

The Food and Drug Administration has approved the use of gemtuzumab (Mylotarg) for the treatment of adults with acute myeloid leukaemia whose tumours express the CD33 antigen.…

FDA approves cancer therapy using genetically engineered cells

The US Food and Drug Administration has approved the first gene therapy, which will be available to children and adults with acute lymphoblastic leukaemia.…

FDA and EMA sign confidentiality commitment

Medicine inspectors in the European Union will be given access to secret and commercially sensitive information by the Food and Drug Administration (FDA) in the US, after signing a new confidentiality commitment.…

FDA to examine opioid-containing cough medicine for children

The US drug safety watchdog is convening a panel of experts to consider the risks and benefits of opioid-containing prescription cough medicine for children.…

Quality of FDA fast-track approvals evidence questioned by research

Research suggests that the US medicines agency has approved indications for many drugs in response to data from less rigorous trials, despite the randomised controlled trial being the ‘gold standard for approval’.…