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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