The FDA has expanded the use of Pfizer’s Ibrance to include use in breast cancer in men based on a filing that drew heavily on post-marketing and real-world data.
The director of the US National Cancer Institute, Norman “Ned” Sharpless has been announced as the acting FDA commissioner, following the shock resignation of incumbent Scott Gottlieb.
The FDA has approved Janssen’s antidepressant nasal spray Spravato, making it the first new type of depression treatment to hit the market in 30 years – although its use will be restricted
Roche has announced that the FDA has granted Priority Review to two of its drugs – personalised lung cancer medicine entrectinib and lymphoma treatment polat