Nonsteroidal anti-inflammatory drugs (NSAIDs) have been used therapeutically since the 1960s.1 Evidence of adverse cardiovascular outcomes led to the withdrawal of the selective COX-2 inhibitor rofecoxib in September 2004, when the question of cardiovascular safety of NSAIDs first came into the limelight.2 Valdecoxib (Bextra) was subsequently withdrawn from the market in April 2005 due to…
(Reuters)—Dr. Scott Gottlieb, a partner at one of the world’s largest venture capital funds and a former deputy commissioner at the U.S. Food and Drug Administration, is being considered by President-Elect Donald Trump to run the agency, according to sources close to the transition team. Gottlieb, 44, a venture partner at New Enterprise Associates and…
A recent study showed that at moderate doses celecoxib may be noninferior with respect to cardiovascular safety compared with ibuprofen or naproxen…
The FDA is considering an application for subcutaneous rituximab and has approved an application for etanercept to treat pediatric patients with plaque psoriasis…
A recent study established the equivalency of BI 695501, a biosimilar, to its reference product, adalimumab, for treating patients with rheumatoid arthritis…
A recent analysis found that about 10% of RA patients taking tofacitinib do not follow recommended guidelines and more than half stop treatment by one year…
To speed the development of tocilizumab to treat giant cell arteritis (GCA), the FDA designated it as a breakthrough therapy earlier this month…
Abaloparatide for Osteoporosis Abaloparatide is completing Phase III clinical trials for the potential treatment of postmenopausal osteoporosis in women who are at an increased risk of fracture.1 Abaloparatide is a synthetic peptide that engages the parathyroid hormone receptor and has favorable bone building activity. Abaloparatide has completed Phase 3 development for use as a daily…
Due to serious side effects from the combined use of opioids and benzodiazepines, the FDA has issued boxed warnings for both types of medication…
Adalimumab-atto, a biosimilar to adalimumab (Humira), has been approved by the FDA to treat multiple autoimmune diseases…