USFDA

The United States Food and Drug Administration (FDA) has granted Fast Track designation to Trevena's oliceridine (TRV130) for the management of moderate-to-severe acute pain. Oliceridine is being developed as a potential replacement for currently approved intravenous opioid analgesics.

AbbVie, a global biopharmaceutical company, announced its New Drug Application (NDA) has been accepted by the U.S. Food and Drug Administration (FDA) for a once-daily, fixed-dose formulation of the components of VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets). VIEKIRA PAK is an all-oral, interferon-free treatment approved with or without ribavirin (RBV) in the United States for patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including those with compensated cirrhosis. VIEKIRA PAK is not for people with decompensated cirrhosis.

Greatbatch, Inc. announced that it has received approval from the United States Food and Drug Administration (FDA) for its Algovita® Spinal Cord Stimulation (SCS) System to treat chronic intractable pain of the trunk and/or limbs.

PhaseBio Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company and leader in the field of biopolymer-based drugs, focused on developing treatments for metabolic and specialty cardiopulmonary disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Vasomera (PB1046) Injection for the treatment of cardiomyopathy associated with dystrophinopathies: Duchenne muscular dystrophy (DMD), Becker muscular dystrophy (BMD) and X-linked dilated cardiomyopathy (XL-dCMP).

U.S. Food and Drug Administration granted approval for Empliciti (elotuzumab) in combination with two other therapies to treat people with multiple myeloma who have received one to three prior medications.

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The U.S. Food and Drug Administration  approved Fluad, the first seasonal influenza vaccine containing an adjuvant. Fluad, a trivalent vaccine produced from three influenza virus strains (two subtype A and one type B), is approved for the prevention of seasonal influenza in people 65 years of age and older.

The U.S. Food and Drug Administration approved a new indication for BioThrax (Anthrax Vaccine Adsorbed) to prevent disease following suspected or confirmed exposure to Bacillus anthracis, the bacterium that causes anthrax disease. The vaccine’s new use is approved for people 18 through 65 years of age in conjunction with recommended antibiotic treatment. BioThrax was initially approved by the FDA in 1970 for the prevention of anthrax disease in persons at high risk of exposure.

The U.S. Food and Drug Administration  approved Opdivo (nivolumab) to treat patients with advanced (metastatic) renal cell carcinoma, a form of kidney cancer, who have received a certain type of prior therapy.

U.S. Food and Drug Administration granted approval for Ninlaro (ixazomib) in combination with two other therapies to treat people with multiple myeloma who have received at least one prior therapy. Ninlaro is marketed by Takeda Pharmaceuticals based in Osaka, Japan.