Late last week, FDA approved a new drug to treat acute myeloid leukemia (AML), the first treatment for Batten disease, and expanded the use of a current drug to treat liver cancer.
A new abuse-deterrent painkiller - oxycodone hydrochloride (RoxyBond, Inspirion Delivery Services) - will be available soon after receiving FDA approval.
In what is expected to produce hefty saving for rheumatoid arthritis patients and the healthcare system, FDA approved the second biosimilar to Remicade (Johnson & Johnson).
Meridian Medical Technologies, Mylan's manufacturing partner for the EpiPen Auto-Injector, expanded a voluntary recall of the EpiPen and EpiPen Jr. epinephrine auto-Injectors to now include additional lots distributed in the United States and other markets.
FDA 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.
Mylan received approval from FDA to market its desvenlafaxine extended-release tablets, the generic version of Pristiq (Pfizer), for major depressive disorder. Plus, 2 other manufacturers recently received approval for their generic versions of Pristiq.
FDA recently approved 2 tests that will aid healthcare providers in determining which antibiotics are needed, leading to better antibiotics management.
A 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.
A 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.
Marathon 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.