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Two U.S. Food and Drug Administration committees recently voted 18 to 8, with one abstention, that Endo International’s OPANA ER (oxymorphone hydrochloride extended release) no longer has a positive risk-to- benefits ratio. Read More »
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The U.S. Food and Drug Administration recently issued Investigational New Drug clearance for Servier’s UCART19, allowing the company to proceed with clinical development of the allogeneic, gene-edited cellular therapy. Read More »
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Mylan N.V. recently launched its Desvenlafaxine extended-release tablets, a generic version of Pfizer’s Pristiq tablets, to treat major depressive disorder in the U.S. market in 50 and 100 mg doses. Read More »
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The results from Amgen’s four-year follow up OSLER-1 study on Repatha, which is so far the longest PCSK9 inhibitor clinical trial, were recently published in JAMA Cardiology. Read More »
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The U.S. Patent and Trademark Office Patent Trials and Appeal Board recently upheld four patents held by Acorda Therapeutics Inc. related to its AMPYRA (dalfampridine) Extended Release Tablets in 10 mg dosages. Read More »
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The U.S. Food and Drug Administration has accepted Allergan PLC's filing of a supplemental New Drug Application based on new clinical data that would allow the company to list maintenance on its product label for VRAYLAR (cariprazine), a drug used to treat adults with schizophrenia. Read More »
The Office of Tissue Advancement Therapies, a branch of the Center for Biologics Evaluation and Research of the FDA, has progressed toward the acceptance of Ampio Pharmaceuticals' Ampion for a viable treatment option for severe osteoarthritis of the knee. Read More »
Merck, which is known as MSD outside the United States and Canada, and Pfizer Inc. recently announced the acceptance for review of three New Drug Applications by the U.S. Food and Drug Administration. Read More »
The Food and Drug Administration has approved ALK's Biologics License Application for a sublingual immunotherapy tablet aimed at combating the negative effects caused by dust mite allergies. Read More »
The U.S. Food and Drug Administration has approved Noctivia nasal spray for adults who deal with nocturnal polyuria, a condition that causes overproduction of urine during the night. Read More »
The FDA has approved the New Drug Application from Teva Pharmaceutical Industries Ltd. and granted Priority Review for SD-809, a treatment for tardive dyskinesia. Read More »
The U.S. Food and Drug Administration recently reclassified Class I devices, which are antigen-based rapid influenza antigen detection systems that are meant to detect the virus from clinical specimens, to Class II devices that are subject to special controls, according to PRNewswire. Read More »
The U.S. Food and Drug Administration has granted Perrigo Co. final approval for hydrocodone bitartrate and homatropine methylbromide oral solution (syrup) 5 mg/1.5mg per 5 mL. Read More »
The U.S. Food and Drug Administration has approved deflazacort, a new treatment for Duchenne muscular dystrophy in patients 5 years and older. Read More »
The Lower Drug Costs through Competition Act created by the House Energy and Commerce Committee was taken off the committee’s fast track on Feb. 3 Read More »
Biotech company Amgen submitted an application to the U.S. Food and Drug Administration for Blincyto, a drug used in the treatment of lymphoblastic leukemia, to broaden its uses and treatments. Read More »
The European Commission has granted Eli Lilly & Co. marketing rights for Olumiant, a drug used to treat patients suffering with severe rheumatoid arthritis. Read More »
The U.S. Food and Drug Administration approved Amgen's Parsabiv for the treating of secondary hyperparathyroidism in adults with chronic kidney failure and is administered at dialysis locations throughout the country. Read More »
A U.S. appeals court suspended a permanent injunction on Praluent, a cholesterol management drug, allowing Regeneron Pharmaceuticals to once again manufacture, market, sell and ship the drug around the world. Read More »
PharmaSmart International, a specialist in blood pressure kiosks, announced that its machines meet new Centers for Disease Control guidelines. Read More »
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