Teva Pharm Generic Pomalidomide Receives Approval in the U.S.
Mylan's Generic Pomalidomide Receives Approval in the U.S.
STOCKHOLM, Jan. 13, 2022 /PRNewswire/ -- Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, today announces that the data from the randomized head-to-head phase 3 OCEAN study, evaluating the efficacy and safety of melflufen (INN melphalan flufenamide) plus dexamethasone versus pomalidomide plus dexamethasone in lenalidomide refractory patients with relapsed refractory multiple myeloma (RRMM) that have received 2-4 prior lines of therapy, have been published in the Lancet Hematology. The OCEAN study was initiated in 2017 and includes 495 patients from 108 hospitals in 21 countries across Europe, North America, and Asia.
Pharmascience's Generic Bortezomib Receives Approval in the U.S.
Dr. Reddy's Generic Pomalidomide Receives Approval in the U.S.
Dr. Reddy`s Laboratories`s Generic Pomalidomide Receives Tentative Approval In US
SAN DIEGO, Nov. 12, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that the Janssen Pharmaceutical Companies submitted regulatory applications to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking approval of the daratumumab subcutaneous (SC) formulation, known as DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj) in the U.S. and as DARZALEX® (daratumumab) SC in the European Union (EU). The applications seek approval of the combination of DARZALEX FASPRO™/ DARZALEX® SC with pomalidomide and dexamethasone (D-Pd) for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. As a fixed-dose formulation, DARZALEX FASPRO™/ DARZALEX® SC can be administered over approximately three to five minutes under the skin, significantly less time than the intravenous (IV) formulation of DARZALEX®, which is given over several hours.
Covering thalidomide, lenalidomide, and pomalidomide: temporary guidance for pregnancy prevention arrangements for patients taking them during COVID-19
Bristol Myers says Pomalyst (pomalidomide) was approved by the U.S. FDA for patients with AIDS-related Kaposi sarcoma whose disease has become resistant to highly active antiretroviral therapy, or in patients who are HIV-negative.
Bristol Myers Squibb announced that Pomalyst (pomalidomide) was approved by the US Food and Drug Administration (FDA) for patients with AIDS-related Kaposi sarcoma whose disease has become resistant to highly active antiretroviral therapy (HAART), or in patients with Kaposi sarcoma who are HIV-negative. Patients with AIDS-related Kaposi sarcoma should continue HAART for their HIV as recommended by their physician. Pomalyst was granted accelerated approval, Breakthrough Therapy designation and Orphan Drug designation in these indications based on overall response rates observed in a Phase 1/2 open label, single-arm clinical trial (12-C-0047). Continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.