The FDA has handed AstraZeneca a green light to begin marketing dapagliflozin, its long-delayed SGLT2 diabetes drug, which will now try to defy the steadily dwindling expectations of market analysts. The treatment--the first new FDA drug approval for 2014--will be sold as Farxiga.
Two years after a stinging rejection at the hands of the same committee, Bristol-Myers Squibb and AstraZeneca got a warmer reception for their diabetes drug dapagliflozin, winning a recommendation from an FDA advisory panel and brightening their odds of approval for the once-rebuffed therapy.
AstraZeneca and Bristol-Myers Squibb are heading back to the FDA with the once-spurned dapagliflozin, claiming they've addressed the diabetes drug's cancer risks, but agency staff remains wary of the novel treatment's dangers.
AstraZeneca and Bristol-Myers Squibb are trying once again to get U.S. approval for their drug dapagliflozin, an innovative but potentially risky treatment for Type 2 diabetes.
AstraZeneca and Bristol-Myers Squibb were stiff-armed by the FDA on their application for the SGLT2 diabetes drug dapagliflozin, but European regulators believe the benefits outweighed the risks that pushed the agency to reject the innovative therapy early this year.
Determined to build its stake in the fast-growing diabetes market, Johnson & Johnson plans to showcase late-stage data this weekend on its promising SGLT2 drug candidate that has drawn both praise and skepticism from clinicians and analysts.
Several drug companies received nods of support for getting their prized drugs approved for the European market.
After Amylin reportedly declined BMS' recent buyout offer, Bristol isn't giving up on its plans to gobble up the diabetes drugmaker, The Wall Street Journal reported.
Don't look for Bristol-Myers Squibb ($BMY) to back away from its ambitious, multibillion-dollar R&D strategy anytime this year. After racking up a billion dollars in research expenses for the
The FDA has surprised no one with its decision to bat down dapagliflozin, an innovative but potentially risky new approach to treating diabetes. AstraZeneca ($AZN) and Bristol-Myers Squibb ($BMY)