Intercept Pharmaceuticals has accused the FDA of moving the goalposts during its review of a potential blockbuster drug for the fatty liver disease known as NASH following a rejection.
The FDA has revoked its Emergency Use Authorization for hydroxychloroquine as a treatment for COVID-19, drawing the ire of president Donald Trump who has repeatedly backed the drug despite
The FDA has extended its review of Novartis’ potential multiple sclerosis drug ofatumumab, pushing back a decision on the repurposed cancer drug until September this year.
Novartis will receive extra help from the FDA during the development of its CAR-T cancer cell therapy Kymriah for follicular lymphoma, after the regulator deemed it to be an advanced regene
The FDA has backed the first COVID-19 diagnostic with a home collection option, at a time when the US is struggling to keep pace with the pandemic and suffering from a shortage of tests.