The FDA has shrugged off Sprout Pharmaceuticals' female libido drug, further delaying the years-long quest to develop a Viagra equivalent for women, but the drugmaker is appealing the rejection, arguing that the agency is misunderstanding how to measure efficacy.
Tomorrow Merck will take its best shot at convincing a group of FDA advisers that its sublingual allergy pill Grastek deserves a place in the nation's pharmacies.
The FDA will soon add 10 drug inspectors to its office in China to help oversee that country's vast API and drug production industry. If the FDA's experience in India is an indicator, it will mean a raft of enforcement actions in a country that is considered to have weak enforcement by its own agency.
Two years and $100 million removed from a devastating FDA roadblock, Orexigen Therapeutics is again knocking on the agency's door with its weight-loss drug Contrave, filing an NDA with fresh hopes that it wins approval and succeeds in a tough market.
Sanofi's Genzyme snagged a 6-month priority review from the FDA for what could become the first oral treatment for Gaucher disease, a rare genetic disorder that causes abnormal fat buildup in cells, enlarging organs in the body.
In its legal battle with much-larger St. Jude Medical, medical device company AccessClosure will walk away with a concession prize: They escape the threat of an injunction over their vascular puncture technology.
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 treatment's dangers.
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.
Novo Nordisk noted today that the Danish Financial Supervisory Authority informed it of its decision to call in the cops after concluding that Novo Nordisk didn't obey the letter of the law as written in Section 27 (1) of the Danish Securities Trading Act.
After a touch-and-go review from FDA staff, Takeda's inflammatory bowel disease drug had an easier time convincing an agency advisory panel of its safety and efficacy. But while an FDA committee took little issue with vedolizumab's risk profile, Takeda may have a hard time convincing regulators to make its treatment an early option for patients.