FDA Approves Oral Testosterone Replacement Therapy Tlando
The approval was based on data from a phase 3 study that evaluated the efficacy and safety of Tlando in 95 adult hypogonadal male patients.
The approval was based on data from a phase 3 study that evaluated the efficacy and safety of Tlando in 95 adult hypogonadal male patients.
The approval was based on data from the phase 3b SUSTAIN FORTE trial, which compared Ozempic 2 mg to 1 mg in adults with type 2 diabetes.
The phase 3 PaTHway trial included 82 adults with chronic hypoparathyroidism.
The Company acquired exclusive rights to commercialize the product from Tris Pharma in February 2021.
Findings showed that patients treated with empagliflozin were 36% more likely to experience a clinical benefit.
Betaine Anhydrous Powder is a methylating agent indicated for the treatment of homocystinuria to decrease elevated homocysteine blood concentrations.
The EUA was supported by data from the phase 2 BLAZE-4 trial which evaluated bebtelovimab in nonhospitalized patients with mild to moderate COVID-19.
Vabysmo is a humanized bispecific antibody that works by inhibiting the angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A) pathways.
The Omnipod 5 System consists of a tubeless wearable Pod, the Omnipod 5 mobile app, and the Dexcom G6 Continuous Glucose Monitoring System.
The recall does not pertain to the interchangeable biosimilars, Semglee (insulin glargine-yfgn) injection, or Insulin Glargine (insulin glargine-yfgn) injection.