The manufacturer of bevacizumab (Avastin), snagged FDA approval for yet another type of cancer.
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 approved the first biosimilar to Neulasta, as well as a new combination treatment for osteoarthritis pain and hypertension and a new drug to treat chronic lymphocytic leukemia.
The manufacturer of two cancer drugs hiked the price on the medicines despite President Donald Trump’s new plan to lower drug prices.
FDA is warning that 2 liquid-filled intragastric balloon systems used to treat obesity are causing deaths in some patients
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.