/ /

FDA approval

Expedited FDA approval plays dominant role in drug approvalsLast year was a banner year for generic drug approvals by the FDA. Find out what’s in store for 2017.
FDA approvals for specialty drugs to pick up in 2017Numerous specialty medications, generics, and biosimilars, are expected to be approved this year for cancer, inflammatory and autoimmune diseases, and other indications.
Five things to know about Trump’s FDA lead pick GottliebOn March 10, the White House announced that President Donald Trump selected Scott Gottlieb, MD, who has worked for FDA in the past, as his choice to head the FDA. Here are five things managed healthcare executives should know about the pick.
9 Newly Approved Novel Drugs
9 Newly Approved Novel DrugsIt's still early in 2017, but the FDA has been approving drugs left and right. Here's what you need to know.
New Parkinson's drug, 2 others approvedFDA approved safinamide (Xadago, Newron Pharmaceuticals) tablets as an add-on treatment for patients with Parkinson’s disease. FDA also approved new treatments for classical Hodgkin lymphoma and pemphigus vulgaris, a rare, life-threatening condition characterized by progressive painful blistering of the skin and mucous membranes.
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.
Once-daily diabetes drug approvedFDA approved 10 mg dapagliflozin and 5 mg saxagliptin (Qtern, AstraZeneca), to treat type 2 diabetes.
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.
Muscular dystrophy drug launch halts after pricing concernsMarathon Pharmaceuticals is temporarily pausing the launch of its drug to treat a rare form of muscular dystrophy (MD) after concerns over its $89,000 price tag.