FDA backs Glenmark's rival to AZ's blockbuster Farxiga

AstraZeneca’s diabetes drug Farxiga could face generic competition in the US, after the FDA gave tentative approval to a generic rival from India’s Glenmark, although it is unclear when the

Janssen files MS pill, ahead of FDA decision on BMS' rival

Janssen has filed its ponesimod pill with the FDA for treatment of adults with relapsing multiple sclerosis, days before the regulator is due to make a decision on a rival from Bristol-Myer

FDA guides on running clinical trials during coronavirus out...

The FDA has responded to concerns about the impact on clinical trials of the novel coronavirus with guidance on how to modify trial designs to mitigate the impact of the COVID-19 crisis.

‘Predatory’ drugmakers exploit FDA’s unapproved drug scheme;...

FDA starts review of Pfizer, Lilly’s non-opioid painkiller

Coronavirus has caused drug shortage, says FDA chief

The FDA has announced the first drug shortage caused by the COVID-19 coronavirus outbreak, following previous warnings about its impact on the drug supply chain.