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News Topic - FDA

RSS feedDisplaying articles 1 - 10 of most recent articles

FDA recommends another trial for Novan treatment The U.S. Food and Drug Administration has advised Morrisville-based Novan (Nasdaq: NOVN) that another trial should be conducted when it comes to progressing the companys lead drug candidate, SB204 for the treatment of acne, toward approval. Novan previous
Triangle Business Journal | 14 hours, 17 minutes ago | comment? | recommend article from Raleigh, North Carolina
U.S. FDA joins Interpol crackdown on illicit online pharmacies (Reuters) - Authorities from a record 123 countries, including the U.S. Food and Drug Administration, have taken action against hundreds of businesses suspected of illegally selling medicines over the internet, officials said on Monday.
Reuters | 17 hours ago | comment? | recommend
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FDA announces criminal, civil actions filed against Aegerion The Food and Drug Administration has responded to charges filed against Aegerion Pharmaceuticals, Inc., of violating the Federal Food, Drug and Cosmetic Act.
United Press International | 17 hours, 20 minutes ago | comment? | recommend
FDA declines to approve J&J arthritis drug sirukumab By Toni Clarke (Reuters) - (The Sept. 22 story has been corrected to remove the reference to Humira being a Jak-inhibitor in the final paragraph. Humira is a TNF-inhibitor.) The U.S. Food and Drug Administration has declined to approve Johnson & Johnson's
Yahoo! News | 18 hours, 42 minutes ago | comment? | recommend
FDA declines to approve Intellipharma's opioid painkiller (Reuters) - Intellipharmaceutics International Inc said on Monday the U.S. Food and Drug Administration (FDA) declined to approve its long-acting opioid painkiller in its current form, backing its independent advisory panel that had raised concerns over t
Reuters | 21 hours, 37 minutes ago | comment? | recommend
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA's immediate steps to respond to Hurricane Maria and ongoing recovery efforts related to H SILVER SPRING, Md., Sept. 22, 2017 /PRNewswire-USNewswire/ -- As the citizens of Puerto Rico and the U.S. Virgin Islands begin the long recovery effort from the devastation brought by Hurricane Maria, I know I'm joined by all of my colleagues at the Food
PR Newswire | Sep 22, 2017 10:56 PM [GMT] | comment? | recommend
Allergan Receives Refusal to File Letter from FDA for Vraylar (cariprazine) Supplemental New Drug Application (sNDA) for the Treatment of Negative Sym DUBLIN, Sept. 22, 2017 /PRNewswire/ -- Allergan plc (NYSE: AGN) today announced that it received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) regarding its Supplemental New Drug Application (sNDA) for Vraylar (cariprazin
PR Newswire | Sep 22, 2017 8:49 PM [GMT] | comment? | recommend
Why Intercept Pharmaceuticals Is Sinking Again Today The future of Intercept's liver disease drug hangs in the balance after an FDA warning letter.
Fool.com | Sep 22, 2017 8:21 PM [GMT] | comment? | recommend
Janssen Receives Complete Response Letter From U.S. FDA For Sirukumab Biologics License Application HORSHAM, Pa., Sept. 22, 2017 /PRNewswire/ -- Janssen Biotech, Inc. (Janssen) announced today that it has received a complete response letter from the U.S. Food and Drug Administration (FDA) for the Biologics License Application (BLA) seeking approval of s
PR Newswire | Sep 22, 2017 8:15 PM [GMT] | comment? | recommend
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The FDA Is Coming Around to the Idea That Cheese, Microbes, and Mold Can Work Just Fine A regulatory crackdown has frustrated cheesemakers and importers. But there are signs that the FDA is softening its hardline
Time.com | Sep 22, 2017 08:38 AM [GMT] | comment? | recommend