FDA Approves Vemlidy to Treat Chronic Hepatitis B Virus Infection
The U.S. Food and Drug Administration has approved Gilead Sciences’ Vemlidy (tenofovir alafenamide,TAF) 25 mg once-daily treatment for adults with chronic hepatitis B virus(HBV) infection with compensated liver disease.
IDELVION Prevents Bleeds and Reduces Drug Consumption in Hemophilia B Patients
Results from the Phase III PROLONG9FP ongoing extension clinical development program evaluating the long-term efficacy and safety of IDELVION (coagulation factor IX [recombinant], albumin fusion protein) showed that extended prophylaxis treatment regimens effectively prevented bleeds while also reducing overall IDELVION consumption.
Dusquetide Granted Orphan Drug Status to Treat Life-Threatening Immune Disorder
The U.S. Food and Drug Administration granted orphan drug designation to dusquetide (SGX942, Soligenix) for the treatment of macrophage activation syndrome.
FDA Approves Cabometyx for Advanced Renal Cell Carcinoma
The U.S. Food and Drug Administration approved cabozantinib (Cabometyx, Exelixis) to treat advanced renal cell carcinoma (RCC) in patients who have received prior anti-angiogenic therapy.
Drug to Treat Autoimmune Hemolytic Anemia Granted FDA Orphan Drug Status
True North Therapeutics’ TNT009 for the treatment of autoimmune hemolytic anemia, including cold agglutinin disease (CAD), has been granted orphan drug status by the U.S. Food and Drug Administration.
Transforming Hemophilia Care: A New Generation of Extended Half-Life Factor Concentrates
New extended half-life products represent a powerful new tool for improving the care and quality of life for persons with hemophilia.
Empliciti Approved by FDA to Treat Multiple Myeloma
Empliciti (elotuzumab) in combination with Revlimid (lenalidomide) and dexamethasone (a type of corticosteroid) has been approved by the U.S. Food and Drug Administration to treat individuals with multiple myeloma who have received one to three prior medications.
CDC Issues Guidelines for Prescribing Opioids for Chronic Pain
The Centers for Disease Control and Prevention (CDC) has released the CDC Guideline for Prescribing Opioids for Chronic Pain.
FDA Approves Keytruda to Treat Lung Cancer
The U.S. Food and Drug Administration granted accelerated approval for pembrolizumab (Keytruda, Merck & Co.) for treatment of patients with advanced (metastatic)
non-small cell lung cancer.
Newly Approved Drug Reverses Effects of Neuromuscular Blocking Drugs Used During Surgery
The U.S. Food and DrugAdministration approved Merck and Co.’s Bridion (sugammadex) injection to reverse the effects of neuromuscular blockade induced by rocuroniumbromide and vecuronium bromide.
