A new dosing regimen for Turalio® (pexidartinib) is now available for the treatment of adults with symptomatic tenosynovial giant cell tumor associated with severe morbidity or functional limitations and not amenable to improvement with surgery. The recommended dose of Turalio is now 250mg orally twice daily (taken as two 125mg capsules) with a low-fat meal…
The approval was based on data from a phase 3 study which included adults with steroid-resistant active PMR who flared on at least 7.5mg per day of prednisone or equivalent during taper.
The Company is currently evaluating the efficacy and safety of taldefgrobep alfa in patients with SMA in the phase 3 RESILIENT study.
The BLA is supported by a comprehensive data package that includes data from the phase 1/3 ROSALIA study.
A 33 person panel of physicians, registered dietitian nutritionists, and nutritional epidemiologists assessed 24 diets to come up with the final results.
The approval for Idacio was based on a review of data that showed similar pharmacokinetics, efficacy, safety, and immunogenicity to the reference adalimumab product.
SRP-9001 is an investigational gene transfer therapy designed to deliver a shortened, functional component of dystrophin to muscle tissue.
According to a long-term safety study and a separate FDA internal study, Prolia had an increased risk of hypocalcemia in patients with advanced kidney disease on dialysis.
The ongoing phase 3 BE MOBILE 2 study compared the efficacy and safety of bimekizumab to placebo in 332 adults with active ankylosing spondylitis.
The approval was based on data from a phase 3 study which evaluated tofacitinib in adults with active AS who had an inadequate response to at least 2 NSAIDs.
