New Oral Therapy Approved for Iron Deficiency in Adults
The FDA has approved Accrufer (ferric maltol; Shield Therapeutics) for the treatment of iron deficiency in adults.
The FDA has approved Accrufer (ferric maltol; Shield Therapeutics) for the treatment of iron deficiency in adults.
The FDA has expanded the approval of Darzalex (daratumumab; Janssen Biotech) to include use in combination with lenalidomide and dexamethasone in patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to PB2452 (PhaseBio), an investigational reversal agent for ticagrelor.
The Food and Drug Administration (FDA) has approved a split-dosing regimen for Darzalex (daratumumab; Janssen), which provides clinicians the option of splitting the first infusion of daratumumab over 2 consecutive days.
The indication has been changed from “control and prevention of bleeding episodes” to “on-demand treatment and control of bleeding episodes” in adults and children with hemophilia A.
Aminocaprioc Acid Tablets are useful in enhancing hemostasis when fibrolysis contributes to bleeding.
In addition to the 1000mg tablet, Siklos is also available in 100mg tablets.
The approval was based on data from a single-arm, open-label sequential cohort study in which patients received Promacta in combination with horse antithymocyte globulin (h-ATG) and cyclosporine.
The approval was based on data from a randomized, double-blind, double-dummy, actively controlled trial (ECHELON-2) involving 452 patients with certain PTCLs.
Udenyca will be supplied as 6mg/0.6mL preservative-free solution in prefilled syringes for subcutaneous injection.