FDA plans 6 public meetings in August
Six public meetings, conferences or workshops sponsored by the U.S. Food and Drug Administration have been scheduled for August, the FDA reported.
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EPIZYME INC.: Announces FDA Filing Acceptance of New Drug Application and Priority Review for Tazemetostat for the Treatment of Epithelioid Sarcoma
Company Aligns with FDA on Planned Confirmatory Study Design for Tazemetostat in Epithelioid Sarcoma
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PFIZER: FDA Approves Pfizer’s Biosimilar, RUXIENCE™ (rituximab-pvvr), for Certain Cancers and Autoimmune Conditions
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).
U.S. FOOD AND DRUG ADMINISTRATION: FDA warns company marketing unapproved cannabidiol products with unsubstantiated claims to treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety
Agency is expediting work to evaluate regulatory policies related to cannabis and cannabis-derived ingredients like CBD
NOVADOZ PHARMACEUTICALS: Novadoz Pharmaceuticals/MSN Labs gains FDA approval and commences shipping of Pregabalin capsules, the largest generic product launch of the year
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.
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U.S. FOOD AND DRUG ADMINISTRATION: FDA approves first generics of Lyrica
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.
Consumers advised to research before taking CBD as FDA seeks more research
The U.S. Food and Drug Administration has set its sights on working to learn more about the safety of CBD and related products.
APIC BIO: Apic Bio’s APB-102 Receives Orphan Drug Designation from the FDA for the Treatment of Genetic SOD1 ALS
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).
VERTEX PHARMACEUTICALS: Vertex Submits New Drug Application to the U.S. FDA for Triple Combination Regimen of VX-445 (Elexacaftor), Tezacaftor and Ivacaftor in Cystic Fibrosis
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
SUN PHARMA: Introduces Access Program for Patients Prescribed XELPROS in the U.S.
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%.
PARAGON BIOSCIENCES: Launches Qlarity Imaging to Advance the First FDA-Cleared Artificial Intelligence Breast Cancer Diagnosis System
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.
NACS outlines proposals to combat vape sales to minors
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.
PEAR THERAPEUTICS: Announces FDA Submission for Somryst™, a Prescription Digital Therapeutic for the Treatment of Adults with Chronic Insomnia and Depression
The pending submission is supported by data from two randomized controlled clinical trials of more than 1,400 patients
ALLERGAN PLC: U.S. FDA Accepts Allergan's New Drug Application for Bimatoprost Sustained-Release in Patients with Open-Angle Glaucoma or Ocular Hypertension
Allergan continues advancement in eye care innovation, developing specialized treatments for patients
30 food, dietary supplement recalls initiated
Food producers carried out 30 food or dietary supplement product recalls over the past month, according to the U.S. Food and Drug Administration.
FDA approves fast-tracking of Parkinson’s treatment
The Food and Drug Administration has Fast Tracked a drug that could provide treatment for those who have Parkinson's Disease
MERCK: FDA Approves Merck’s RECARBRIO™ (imipenem, cilastatin, and relebactam) For the Treatment of Adults with Complicated Urinary Tract and Complicated Intra-Abdominal Bacterial Infections Where Limited or No Alternative Treatment Options Are Available
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.
ERCHONIA: FDA Clears Erchonia's FX 635 for Relief of Chronic Musculoskeletal Pain
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.
U.S. FOOD AND DRUG ADMINISTRATION: FDA approves new treatment for complicated urinary tract and complicated intra-abdominal infections
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).
Treatment approved for rhinosinusitis with nasal polyps
Dupixent, an injectable medication, was approved by the Food and Drug Administration for the treatment of chronic rhinosinusitis (prolonged inflammation of the sinuses and nasal cavity) with nasal polyps (growths on the inner lining of the sinuses).