Pharma News

Monthly News Roundup - January 2018 (Tue, 30 Jan 2018)
Opdivo Gains New Adjuvant Use in Melanoma Adjuvant therapy can reduce the risk of cancer recurrence follow surgery that removes the tumor and lymph nodes. Bristol-Myers Squibb’s Opdivo (nivolumab) is now the first PD-1 inhibitor approved as...
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FDA, FTC Warn Companies for Selling Illegal, Unapproved Opioid Cessation Products Using Deceptive Claims (Wed, 24 Jan 2018)
January 24, 2018 -- The U.S. Food and Drug Administration and the Federal Trade Commission today posted joint warning letters to the marketers and distributors of 12 opioid cessation products, for illegally marketing unapproved products with claims...
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Monthly News Roundup - December 2017 (Sun, 31 Dec 2017)
Luxturna Gene Therapy OK’d for Rare Form of Vision Loss A historic approval, Luxturna (voretigene neparvovec-rzyl) from Spark Therapeutics is the first directly administered gene therapy that targets a disease caused by specific gene...
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FDA Permits Marketing of Device to Treat Diabetic Foot Ulcers (Thu, 28 Dec 2017)
Today, the Food and Drug Administration permitted the marketing of the Dermapace System, the first shock wave device intended to treat diabetic foot ulcers. “Diabetes is the leading cause of lower limb amputations,” said Binita Ashar, M.D.,...
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FDA Clears Stereotactic Radiotherapy System for Use in Treating Breast Cancer (Fri, 22 Dec 2017)
December 22, 2017 -- Today, the U.S. Food and Drug Administration cleared a new noninvasive stereotactic radiotherapy system intended for use in treating cancer in breast tissue. “With today’s clearance, patients will have access to a treatment...
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FDA Proposes New, Risk-Based Enforcement Priorities to Protect Consumers from Potentially Harmful, Unproven Homeopathic Drugs (Mon, 18 Dec 2017)
Today, the Food and Drug Administration proposed a new, risk-based enforcement approach to drug products labeled as homeopathic. To protect consumers who choose to use homeopathic products, this proposed new approach would update the FDA’s...
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FDA Launches New Tool for Sharing Information That Allows Doctors to Better Manage Antibiotic Use (Wed, 13 Dec 2017)
Today the Food and Drug Administration is announcing a new approach to get critical updates regarding antibiotics and antifungal drugs to health care professionals as part of an overall effort to combat antimicrobial resistance. The agency created a...
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