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.
FDA recently approved 2 new therapies: an expanded drug indication for locally advanced or metastatic urothelial carcinoma (mUC) and a treatment for secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.
In the latest flap over the high cost of drugs, diabetes patients filed a class-action lawsuit against insulin makers.