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The U.S. Food and Drug Administration has approved Recarbrio (imipenem, cilastatin and relebactam), an antibacterial drug product to treat adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI).
Erchonia Corporation, the global leader in the manufacturing and development of low level laser therapy technology ("3LT"), announces that the U.S. Food and Drug Administration (FDA) has granted the company 510(k) clearance to market its FX 635 low level laser for the temporary relief of chronic, nociceptive musculoskeletal pain.
Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved RECARBRIO™ (imipenem, cilastatin, and relebactam) for injection, 1.25 grams, a new combination antibacterial. RECARBRIO is indicated in patients 18 years of age and older who have limited or no alternative treatment options, for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by the following susceptible Gram-negative microorganisms: Enterobacter cloacae, Escherichia coli, Klebsiella aerogenes, Klebsiella pneumoniae, and Pseudomonas aeruginosa.
The Food and Drug Administration has Fast Tracked a drug that could provide treatment for those who have Parkinson's Disease
Food producers carried out 30 food or dietary supplement product recalls over the past month, according to the U.S. Food and Drug Administration.
Allergan continues advancement in eye care innovation, developing specialized treatments for patients
The pending submission is supported by data from two randomized controlled clinical trials of more than 1,400 patients
With the rise of e-cigarettes and other popular vape products being consumed by young people, government entities are scrambling to find a solution to address the problem.
Paragon Biosciences LLC — the Chicago-based life science innovator that invests in, builds, and advises bioscience companies — is announcing the launch of its seventh portfolio company, Qlarity Imaging LLC, which was founded to harness the value of artificial intelligence (AI) to improve medical outcomes.
Sun Ophthalmics, the branded ophthalmic division of Sun Pharmaceuticals Inc, USA, which is a wholly owned subsidiary of Mumbai-based Sun Pharmaceutical Industries Ltd. (Sun Pharma), has launched XELPROS Xpress™ - an access program for patients prescribed XELPROS™ (latanoprost ophthalmic emulsion) 0.005%.
Application supported by positive results from two global Phase 3 studies in people with CF ages 12 and older with one F508del mutation and one minimal function mutation and in people with two F508del mutations
Apic Bio, Inc., an innovative gene therapy company developing novel treatment options for patients with rare genetic diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to APB-102, a gene therapy soon to be in clinical development for the treatment of genetic SOD1 amyotrophic lateral sclerosis (ALS).
The U.S. Food and Drug Administration has set its sights on working to learn more about the safety of CBD and related products.
On July 19, the U.S. Food and Drug Administration approved multiple applications for first generics of Lyrica (pregabalin) for the management of neuropathic pain associated with diabetic peripheral neuropathy, for the management of postherpetic neuralgia, as an adjunctive therapy for the treatment of partial onset seizures in patients 17 years of age and older, for the management of fibromyalgia, and for the management of neuropathic pain associated with spinal cord injury.
Novadoz Pharmaceuticals, the U.S based sales & marketing affiliate for MSN Labs, based in Hyderabad India, has received FDA approval for their generic version of Pregabalin capsules on July 19th. The patent expiration for the brand Lyrica© marketed by Pfizer, occurred on that day which cleared the way for the company to begin immediate shipping of the product.
Agency is expediting work to evaluate regulatory policies related to cannabis and cannabis-derived ingredients like CBD
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Pfizer Inc. (NYSE:PFE) announced the United States (U.S.) Food and Drug Administration (FDA) has approved RUXIENCE™ (rituximab-pvvr), a biosimilar to Rituxan® (rituximab),1 for the treatment of adult patients with non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), and granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).
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Company Aligns with FDA on Planned Confirmatory Study Design for Tazemetostat in Epithelioid Sarcoma
Six public meetings, conferences or workshops sponsored by the U.S. Food and Drug Administration have been scheduled for August, the FDA reported.
The U.S. Food and Drug Administration today took significant action to protect women from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) by requesting that Allergan, the manufacturer of a specific type of textured implant, recall specific models of its textured breast implants from the U.S. market due to the risk of BIA-ALCL.