While FDA has approved other continuous glucose monitoring (CGM) systems, it just approved the first system that includes a fully implantable sensor to detect glucose.
A generic manufacturer is fighting a restraining order against its sale of one of the first generic versions of buprenorphine and naloxone (Suboxone) sublingual film to treat opioid dependence, after FDA approved them late last week.
FDA’s new guidances on Risk Evaluation and Mitigation Strategy (REMS) requirements aims to help generic and biosimilar drugs get to market faster.
FDA is asking manufacturers to immediately stop selling OTC products containing the pain reliever benzocaine (such as Orajel) for teething in infants or children.
While the pharmaceutical industry has made tremendous advances in new drug development this year, FDA has also had to remove drugs from the market or investigate problem drugs. Here are the top 3 drug warnings and problems so far in 2018.
The first-and-only antidote indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding, will begin a limited rollout in June.
The top 3 new US drug approvals include the first non-opioid treatment for opioid withdrawal, a migraine prevention drug, and the first biosimilar for anemia. Here are the top 3 new drugs, approved within the last week.
FDA approved fingolimod (Gilenya, Novartis) for the treatment of children and adolescents aged 10 years to less than 18 years who have relapsing forms of multiple sclerosis (MS)—the first disease-modifying therapy indicated for these pati
Major drug store chains — along with pharmacist organizations — praised President Donald Trump’s new plan to lower prescription drug prices.
A new deal between pharma giants AbbVie and Samsung Bioepis is designed to postpone competition against a biosimilar to Humira until 2023.