formulations of products to serve the needs of overlooked patients, announced that the U.S. Food and Drug Administration (FDA) has approved Myhibbin™, the only ready-to-use mycophenolate mofetil oral suspension. Mycophenolate mofetil is an...
Octapharma USA, Inc. announced the U.S. Food and Drug Administration (FDA) has granted orphan drug exclusivity for wilate®, von Willebrand Factor/Coagulation Factor VIII Complex (Human) Lyophilized Powder for Solution for Intravenous Injection,...
for Injection to wholesale partners this week. The Company is supported by a global network of development and FDA-approved cGMP-certified contract manufacturing partners. Eptifibatide for Injection had U.S. sales of approximately $8.3 million for...
Genmab A/S announced the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for TIVDAK® (tisotumab vedotin-tftv) for the treatment of patients with recurrent or metastatic cervical cancer...
and offer a proven path to commercialization. They are also safe, fast, and easy-to-use. The Stratis® System has U.S. FDA 510(k) marketing clearance, CE Mark, and WHO PQS certification to deliver medications and vaccines either intramuscularly or...
and durability of this technology. The quality of this data and our rigorous test methods were validated with the full FDA IDE approval of the US study. The initiation of these studies is a critical step on the path to providing Hyalex technology...
ImmunityBio, Inc. an immunotherapy company, today announced that the U.S. Food and Drug Administration (FDA) has approved ANKTIVA (N-803, or nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) for the treatment of patients with...
reduce the risk of post operative complications and improve outcomes following cardiothoracic surgery. RBT-1 has received FDA Breakthrough and Fast Track Designations. "Presenting at EACTS enables Renibus to share our promising RBT-1 results with...
a pivotal Phase III study for advanced liver cancer that has been approved by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and also in a Phase IIb study in patients with MASH. “We are very much...
to dapagliflozin, marketed as Farxiga in the United States, in patients with type 2 diabetes mellitus. BRENZAVVY is an FDA-approved oral sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve...
mitigating neurodevelopmental complications associated with certain epilepsy syndromes.8 Vigabatrin REMS Program: The U.S. FDA has approved a single shared system Risk Evaluation and Mitigation Strategy (REMS) for all vigabatrin products called the...
precision medicine platform to address hard-to-treat cancers, today announced that the U.S. Food and Drug Administration (FDA) cleared the investigational new drug (IND). Application for NST-628 for the treatment of patients with advanced solid...
inhibitor, for use as the first drug ever developed for the treatment of tardive dyskinesia. In 2023, the company received FDA approval for valbenazine as a treatment for chorea associated with Huntington's disease. About Neurocrine Biosciences :...
to better the lives of people impacted by kidney disease, today announced that the U.S. Food and Drug Administration (FDA) has approved Vafseo® (vadadustat). Tablets for the treatment of anemia due to chronic kidney disease (CKD) in adults who have...
in patient-care settings. The test has only been authorized for in-vitro diagnostic use under an EUA and has not been FDA cleared or approved. Multiplex testing provides rapid diagnostic results at the point-of-care, especially as respiratory...
and so on. Dr. Dong-il Han, CEO of Aptamer Sciences Inc., emphasized, "Since the second aptamer drug Izervay approved by FDA last year, aptamer technology has garnered significant attention in the pharmaceutical market," highlighting, "The AST-201...
receiving ST101 before and after surgical resection. ST101 has been granted Fast Track designation for rGBM from the U.S. FDA and orphan designations for glioma from the U.S. FDA and the European Commission. About Sapience Therapeutics: Sapience...
Hemostasis System consists of the Quantra Hemostasis Analyzer with QPlus and QStat Cartridges. The Quantra System is FDA-cleared for use in point-of-care settings, such as operating rooms, intensive care units, and hospital laboratories, and it...
new non-activated four factor prothrombin complex concentrate (4F-PCC), approved by the U.S. Food and Drug Administration (FDA) this summer, is indicated for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K...
