Zogenix Inc. won approval to sell the first painkiller made of pure hydrocodone as U.S. regulators recommended restrictions on popular combination treatments with the drug. The decision helped Zogenix shares climb the most in eight months.
A top U.S. regulator is discrediting research published a year ago that found impurities in dozens of generic heart drugs made overseas, saying the investigators contaminated the samples during their testing.
Drugmakers may win approval from U.S. regulators for “breakthrough” therapies after a single round of studies, rather than three, in an effort to speed them to patients, a Food and Drug Administration official said.
Indian companies supplying a quarter of the medicines used in the U.S. must take responsibility for the quality-control necessary to export their products, the top U.S. drug regulator said as it ramps up inspections.
Half of the 21 drugs pulled from the market in the U.S. for safety reasons since 1995 involved heart complications, a finding that is spurring Congress and doctors to call for closer government review of side effects.
April Hauge, a nurse practitioner in Weimar, California, spent $500 on a genetic test for her autistic son in 2009 that led to purchasing thousands of dollars in vitamins and supplements. Impressed with the results, she’s now selling advice on the approach to others.