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News Topic - FDA

RSS feedDisplaying articles 1 - 10 of most recent articles

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How Older People Can Head Off Drug Interactions Taking multiple medications and supplements could cause serious problems, FDA warns
WebMD | 53 minutes ago | comment? | recommend
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Should FDA Have Power to Recall Beauty Products? The FDA doesnt have the authority to recall beauty products or to test a product for safety until someone complains. Congress has stepped in with proposals to boost its authority.
WebMD | 3 hours, 10 minutes ago | comment? | recommend
Here's Why DURECT Corporation Is Tanking Today News that the FDA has rejected its partner's NDA submission has investors heading for the exits. | 3 hours, 42 minutes ago | comment? | recommend
Pain Therapeutics receives FDA letter saying NDA for opioid analgesic can't be approved Pain Therapeutics Inc. said Monday it received a complete response letter from the Food and Drug Administration saying its new drug application for the opioid Remoxy ER could not be approved in its present form. The company said it was evaluating the lett | 9 hours, 24 minutes ago | comment? | recommend
FDA set to decide on two likely blockbuster drugs by Sanofi Genzyme The second of two potential drugs for immune system disorders that are together expected to bring in peak annual revenues of between $3 billion and $7 billion to Sanofi Genzyme and a New York based partner in the next few years is expected to have a decis | 9 hours, 38 minutes ago | comment? | recommend article from Boston, Massachusetts
FDA approves lower-cost alternative to biotech drug Humira WASHINGTON Federal regulators have approved the first alternative version of the second-biggest selling drug in the world AbbViersquos Humira a blockbuster injection used to treat rheumatoid arthr
San Mateo Daily Journal | Sep 24, 2016 1:53 PM [GMT] | comment? | recommend article from San Mateo, California
Controversy Continues Over Muscular Dystrophy Drug, Despite FDA Approval The Food and Drug Administration approved a muscular dystrophy drug despite deeply flawed evidence. Was the decision a dangerous precedent or flexible pragmatism reflecting patients' values? | Sep 24, 2016 12:47 PM [GMT] | comment? | recommend
The Woman Behind Sarepta Therapeutics' Success Janet Woodcock's advocacy as director of the FDA's Center for Drug Evaluation and Research proved vital to the company's winning accelerated approval of its Duchenne muscular dystrophy drug. | Sep 24, 2016 11:22 AM [GMT] | comment? | recommend
FDA Approves Amgen's AMJEVITA (Adalimumab-Atto) For Treatment Of Seven Inflammatory Diseases THOUSAND OAKS, Calif., Sept. 23, 2016 /PRNewswire/ --Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved AMJEVITA™ (adalimumab-atto) across all eligible indications of the reference product, Humira
PR Newswire | Sep 23, 2016 10:04 PM [GMT] | comment? | recommend
FDA approves Amgen's copy of AbbVie arthritis drug Humira The U.S. Food and Drug Administration on Friday approved Amgen Inc's biosimilar version of AbbVie's top-selling arthritis drug, Humira. The drug, Amjevita, known also as adalimumab-atto, was approved to treat rheumatoid arthritis, psoriatic arthritis, Cro
Yahoo! News | Sep 23, 2016 9:51 PM [GMT] | comment? | recommend