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“The safety and efficacy of SGLT2 inhibitors have not been established in patients with type 1 diabetes, and FDA has not approved them for use in these patients,” the agency said. Read More
“EMA should ensure that there is a separation between those responsible for providing scientific advice to a medicine developer and those…involved in evaluating a marketing authorization application for the same medicine,” the ombudsman said. Read More
The company said it recalled the drugs over public safety concerns and estimates that around 990 vials contained the incorrect hemophilia treatment. Read More
The drug received priority review as a Qualified Infectious Disease Product, a designation for antibacterial and antifungal drug products intended to treat serious or life-threatening infections. Read More
The company’s submission is supported by Phase 2 trial results showing the treatment reduced the median yearly rate of VOCs that led to healthcare visits by 45.3 percent compared to a placebo. Read More
EMA experts who give scientific advice to a drug developer pre-application should not be involved in evaluating the medicine, the EU’s internal watchdog advised last week. Read More
The FDA shot down AstraZeneca’s Farxiga (dapagliflozin) as an adjunct treatment to insulin for type 1 diabetes patients in a complete response letter to the company on Monday. Read More