FDA

What more transparency at the FDA means for health executivesResearchers create a set of recommendations for transparency at the agency in five principal areas.
FDA Approves 800 Generics in 2016, but Legislators Think Process Should Be FasterFDA set a record for generics approval, but is the process still too cumbersome?
Business Group Makes Price Recommendations for Specialty Drugs
Business Group Makes Price Recommendations for Specialty DrugsThe high cost of specialty drugs demands a change in Washington, according to a report.
Two Dietary Supplement Makers Close DoorsAuthorities putting more pressure on supplement manufacturers.
FDA Approves Drug for Treatment of Nocturnal PolyuriaNoctiva is the first agent approved to temporarily decrease urine production in adults with nocturia from various causes.
Gottlieb Tapped for FDA Commissioner SpotFormer FDA deputy commissioner is nominated to take the top job, but financial ties may bind for him.
Once-daily diabetes drug approvedFDA approved 10 mg dapagliflozin and 5 mg saxagliptin (Qtern, AstraZeneca), to treat type 2 diabetes.
Pfizer Receives FDA Warning
Pfizer Receives FDA WarningA Pfizer plant in Kansas is putting patients at risk, according to the FDA
Popular asthma inhaler now expanded to kidsA leading asthma inhaler will now be available to additional younger asthma patients, after FDA approved Spiriva Respimat (Boehringer Ingelheim) for the long-term, once-daily maintenance treatment of asthma in people age 6 and older.
Psoriasis drug approved with boxed warningA new drug to treat moderate-to-severe plaque psoriasis carries a black box warning that suicidal ideas and behavior, including completed suicides, have occurred in patients during the drug’s clinical trials.