Kevzara Approved for Polymyalgia Rheumatica
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 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.
Each capsule contains 140mg of bismuth subcitrate potassium, 125mg of metronidazole, and 125mg of tetracycline hydrochloride.
The Trifecta and Trifecta GT valves are heart valve replacement devices designed to treat diseased, damaged, or malfunctioning native or prosthetic aortic heart valves.
The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for ADX-2191 (methotrexate injection) for the treatment of primary vitreoretinal lymphoma, a rare, aggressive retinal cancer. ADX-2191 is a preservative-free, intravitreal formulation of methotrexate designed to be vitreous-compatible. The application is supported by safety data from the phase 3…
The FDA is requiring the Company to conduct an additional clinical trial evaluating omecamtiv mecarbil for HFrEF.
M-M-R II, Varivax, and ProQuad are supplied in single-dose vials as lyophilized vaccine for SC or IM injection after reconstitution.
The new autoinjector is designed with push-on-skin activation to be used in both in-office and at-home settings of care.
The application is supported by data from the pivotal phase 3 B-SIMPLE4 study which included 891 patients 6 months of age and older with molluscum contagiosum.
The sBLA is supported by data from Studies A and B of phase 3 LIBERTY-CUPID trial which included patients with CSU who were inadequately controlled on standard-of-care H1 antihistamines.
The approval was based on data from the phase 3 DERBY and OAKS studies.