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.
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.
FDA Approves First Coagulation Factor-Albumin Fusion Protein to Treat Hemophilia B
In March, the U.S. Food and Drug Administration (FDA) approved CSL Behring’s Idelvion (coagulation factor IX [recombinant], albumin fusion protein) for on-demand control and prevention of bleeding episodes, management of bleeding following surgery and as a routine preventive measure to reduce the frequency of bleeding episodes in children and adults with hemophilia B. It is […]
Second Biosimilar Drug in U.S. Is Approved by FDA
The U.S. Food and Drug Administration has approved Celltrion’s Inflectra (infliximab-dyyb), a biosimilar version of Johnson & Johnson’s Remicade drug used to treat autoimmune diseases.
FDA Expands Approval of Combination Therapy for Melanoma
The U.S. Food and Drug Administration has approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of patients with BRAFV600 wildtype and BRAFV600 mutation-positive unresectable or metastatic melanoma.
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.
FDA Approves Adynovate to Treat Hemophilia A
The U.S. Food and Drug Administration has approved Baxalta’s Adynovate for use in hemophilia A patients aged 12 years and older.
FDA Issues Guidance to Protect Blood Supply from Zika Virus
The U.S. Food and Drug Administration issued a new guidance recommending the deferral of individuals from donating blood if they have been to areas with active Zika virus transmission, potentially have been exposed to the virus or have had a confirmed Zika virus infection.
