News from the FDA/CDC
News from the FDA/CDC
Approximately 20% of U.S. adults are diagnosed with arthritis
New data show disproportionate arthritis prevalence among women, veterans, non-Hispanic White individuals, and those aged 45 years and older.
News from the FDA/CDC
FDA approves new drug for ulcerative colitis
The approval of etrasimod was based on safety and efficacy data from two randomized, double-blind, placebo-controlled phase 3 trials.
News from the FDA/CDC
Intravenous formulation of secukinumab gets FDA approval
This new route of administration is expected to become available during the fourth quarter of 2023.
News from the FDA/CDC
FDA approves ninth Humira biosimilar, with interchangeability
The drug, adalimumab-afzb (Abrilada), is the second adalimumab biosimilar approved with interchangeability status. It will be available in late...
News from the FDA/CDC
FDA approves first tocilizumab biosimilar
Tocilizumab-bavi (Tofidence) will offer a lower-cost option for patients with autoimmune conditions, the drug manufacturer, Biogen, stated.
News from the FDA/CDC
FDA OKs subcutaneous vedolizumab for UC maintenance therapy
The safety profile of subcutaneous vedolizumab was “generally consistent” with the intravenous form of the drug, with the addition of injection-...
News from the FDA/CDC
FDA gives semaglutide two drug safety–related label changes
The second addition concerns a new adverse reaction that was identified during the postmarketing experience: gastrointestinal ileus, an intestinal...
News from the FDA/CDC
FDA panel deems phenylephrine ineffective
The committee’s next move is to determine if the drug’s status as Generally Recognized as Safe and Effective should be revoked.
Latest News
FDA to step up oversight of cosmetics, assess ‘forever chemicals’
The cosmetic products include makeup products, nail polishes, shaving creams, other grooming products, perfumes, face and body cleansers, hair...
News from the FDA/CDC
FDA approves canakinumab for gout flares
Canakinumab is the first biologic in the U.S. approved for treating gout flares.
News from the FDA/CDC
FDA clears new capabilities for diabetes app BlueStar
The clearance enables the app-based platform to provide bolus insulin dose recommendations that are based on glucose and trend data from a...