Tag Archives: First

FDA approves Lilly’s migraine drug as first ever cluster headache treatment – CNBC

Eli Lilly’s office in La Jolla, California. Konrad Fiedler | Bloomberg | Getty Images Eli Lilly and Co’s migraine treatment Emgality on Tuesday became the first drug to gain U.S. approval for decreasing the frequency of episodic cluster headache attacks, the Food and Drug Administration said. Emgality belongs to a new class of drugs called… Read More »

FDA’s Nutrition Innovation Strategy Makes Progress in First Year – FDA.gov

By: Susan Mayne, Ph.D., Director, Center for Food Safety and Applied Nutrition Susan Mayne, Ph.D. Unhealthy diets are at least partly to blame for chronic diseases like heart disease, cancer and diabetes. This reality is among the reasons that nutrition has and always will be a key priority for the U.S. Food and Drug Administration… Read More »

First, a pricing scandal for Catalyst’s Firdapse. Next, off-label competition?

For decades, Jacobus Pharmaceuticals gave away the unapproved drug amifampridine to patients with a rare neuromuscular disorder called LEMS. Then, Catalyst Pharma licensed certain rights to the drug, scored an FDA nod, and priced the med at $ 375,000 a year. An outcry ensued. But now, the FDA may have given patients a workaround. Jacobus… Read More »