FDA Food & Drug Administration

Type: Organization
Name: FDA Food & Drug Administration (Food and Drug Administration, FDA, Federal Drug Administration)
First reported 3 hours ago - Updated 15 mins ago - 9 reports

Sarepta to Resubmit Application for Duchenne Drug, Shares Boom

The Sarepta Therapeutics rollercoaster ride is back on the upswing.Today, the Cambridge, MA-based company revealed that it’s reached an agreement with the FDA on a clinical plan that will give it a shot to win early approval for its Duchenne Muscular ... [Published Xconomy - 15 mins ago]
First reported 1 hour ago - Updated 18 mins ago - 2 reports

Cubist Pharmaceuticals Inc announces submission of new drug application for investigational antibiotic ceftolozane/tazobactam

1:30pm BST Cubist Pharmaceuticals Inc:Submitts New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for approval of its investigational antibiotic ceftolozane/tazobactam for treatment of Complicated Urinary Tract Infections (cUTI) and ... [Published Reuters UK - 18 mins ago]
First reported 3 hours ago - Updated 22 mins ago - 12 reports

Sarepta Therapeutics jumps on plans to submit new drug application by end of 2014

10:24 am by The company said the plan is based on a guidance letter received from the regulatory agency, which proposed a strategy regarding the submission of an application for the drug, called eteplirsen, under a potential accelerated approval path ... [Published Proactive Investors USA - 22 mins ago]
First reported 1 hour ago - Updated 1 hour ago - 2 reports

AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) Long-Term Investor Alert: Investigation Announced

An investigation for current long-term investors in shares of AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) is ongoing and NASDAQ:AMAG stockholders should contact the Shareholders Foundation.San Diego, CA -- (SBWIRE) -- 04/21/2014 -- An investigation on behalf ... [Published Digital Journal - 1 hour ago]
First reported 3 hours ago - Updated 1 hour ago - 3 reports

Emergent BioSolutions Inc receives Orphan Drug designation for BioThrax for Post-Exposure Prophylaxis of Anthrax Disease

12:00pm BST Emergent BioSolutions Inc:U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to BioThrax (Anthrax Vaccine Adsorbed) for post-exposure prophylaxis (PEP) of anthrax disease resulting from suspected or confirmed exposure ... [Published Reuters UK - 2 hours ago]
First reported 7 hours ago - Updated 3 hours ago - 2 reports

Previewing A 'Juicy' Supreme Court Case On Food Labeling Regulation

Like most consumer packaged goods, the fruit juice industry is highly competitive. To gain an edge with consumers, juice manufacturers can be tempted to make aggressive or questionable claims about their juices. Or should the government’s regulatory agency, ... [Published Atlanta Journal And Constitution - 3 hours ago]
First reported 10 hours ago - Updated 5 hours ago - 2 reports

FDA and EC grant Orphan Drug Designation to Boehringer’s volasertib for acute myeloid leukemia

Boehringer Ingelheim Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) and European Commission (EC) have granted Orphan Drug Designation to volasertib for acute myeloid leukemia (AML). Volasertib is currently being ... [Published News-Medical.Net - 5 hours ago]
First reported 9 hours ago - Updated 5 hours ago - 2 reports

FDA study claiming BPA safety borders on scientific misconduct scientists say

(NaturalNews) Shielding from the public its true allegiances to Big Industry over the people has never been much of a concern at the U.S. Food and Drug Administration (FDA), where public policy is ... ... [Published Big News Network - 5 hours ago]
First reported Apr 20 2014 - Updated 14 hours ago - 3 reports

FDA proposed rule could raise beer prices

The price of beer could be on the rise across the country because of proposed FDA regulations. Local brewers say the ripple effect could hurt the entire U.S. economy.The FDA's proposal is part of the Food Safety and Modernization Act , an effort to prevent ... [Published KOKH Oklahoma City FOX 25 - 14 hours ago]
First reported Apr 20 2014 - Updated 18 hours ago - 2 reports

Sweden's Medical Innovators Headed For US Via The Crowd

It is something of a Holy Grail for many European entrepreneurs with plans to export. The US market is vast, potentially lucrative, but tough And when their products require US Food and Drug Administration (FDA) approval, it gets even tougher. It is a ... [Published Atlanta Journal And Constitution - 21 hours ago]
First reported 20 hours ago - Updated 20 hours ago - 2 reports

Brewers fear proposed FDA rule would spike costs

Northwest brewers are afraid that a proposed rule from the Food and Drug Administration would make it prohibitively expensive for them to recycle their spent grain by providing it to…Click to Continue » ... [Published The Olympian - 20 hours ago]
First reported Apr 19 2014 - Updated Apr 19 2014 - 4 reports

FDA gives green signal to Ragwitek to treat pollen allergies, hay fever

The Food and Drug Administration (FDA) has given its green signal to Ragwitek, an allergen extract, to treat short ragweed pollen induced allergic rhinitis or hay fever.The drug, administered under the tongue, helps in treating hay fever (with or without ... [Published The Utah People's Post - Apr 19 2014]

Quotes

"In February 2014, we learned that the SEC is investigating certain matters relating to our company and an outside investor-relations firm that we retained in 2013. We have been in contact with the SEC staff through our counsel and are cooperating with the investigation" the company stated in its 10-K filing dated Mar. 17
"Due to a lack of punitive measures and no substitute products, the non-degradable plastic bags are still widely used in China despite repeated prohibitions" she said
Coldstream's President & CEO, Eric W Smart added, "We are extremely pleased with the success of this audit. We believe that compliance is not a destination, but a journey. As our portfolio continues to evolve toward commercial products, we recognize our responsibility to pursue the highest standards of quality. The outcome of this PAI tells me we are on the right course."
"With additional data to support the efficacy and safety of eteplirsen for the treatment of DMD, an NDA should be fileable,” the FDA said in the letter, proceeding to outline examples of additional data and analysis that, if positive, will be important in the potential acceptance of the new drug application."

More Content

All (22392) | News (19934) | Reports (3) | Blogs (2113) | Audio/Video (1) | Fact Sheets (39) | Press Releases (221)
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'Refugees' Moving To Colorado Seeking Medical M... [Published Opposing Views - 5 mins ago]
ZOGENIX, INC. : U.S. District Court Judge Nixes... [Published 4 Traders - 5 mins ago]
Digital Pathology: Technologies and Global Markets [Published IT News Online - 6 mins ago]
Chinese mining firm Jinhui launches bioplastic ... [Published Plastics News - 7 mins ago]
COLDSTREAM LABORATORIES COMPLETES SUCCESSFUL FD... [Published Benzinga.com - 12 mins ago]
Sarepta to Resubmit Application for Duchenne Dr... [Published Xconomy - 15 mins ago]
Cubist Pharmaceuticals Inc announces submission... [Published Reuters UK - 18 mins ago]
Weekly FDA Enforcement Report For Drugs And Bio... [Published Pharmaceutical Online - 19 mins ago]
Sarepta Therapeutics jumps on plans to submit n... [Published Proactive Investors USA - 22 mins ago]
The 'iPhone party'? [Published MSNBC - 30 mins ago]
Sarepta Shares Surge on Muscular Dystrophy Drug... [Published Washington Post - 31 mins ago]
Moms-to-Be: Don't Eat These Fish [Published Discovery Channel - 31 mins ago]
Odds of Sarepta Drug Approval Rise Sharply [Published 24/7 Wall St - 33 mins ago]
Burned using Icy Hot, woman claims [Published Sharon Herald - 35 mins ago]
Spine procedure can improve life [Published Robesonian - 36 mins ago]
Teva's injunction on introduction of Mylan's ge... [Published Drug Store News - 37 mins ago]
MARKET PULSE-AMD, Cbeyond, Halliburton, Plug Po... [Published London South East - 40 mins ago]
Cochlear Receives FDA Approval of the Aqua+ Acc... [Published PR Newswire: Consumer Products & Retail - 41 mins ago]
Collagen Matrix Gains Clearance for Flexible Co... [Published ODT Mag - 41 mins ago]
Odds of Sarepta Drug Approval Rise Sharply [Published 24/7 Wall St. - 43 mins ago]
Nuvilex Inc. Could Obtain FDA Accelerated Appro... [Published 4 Traders - 44 mins ago]
MARKET SNAPSHOT: U.S. Stocks Rise As Results Fr... [Published Nasdaq - 47 mins ago]
Branch established for food safety risk communi... [Published CHINAdaily - 48 mins ago]
MARKET SNAPSHOT : U.S. Stocks Rise As Results F... [Published 4 Traders - 48 mins ago]
Better Donor Transport - Organ Care System FDA ... [Published Scientific Blogging - Culture - 50 mins ago]
Soft Tissue Regeneration Announces Completion o... [Published BioPortfolio - 1 hour ago]
AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) Long-T... [Published Digital Journal - 1 hour ago]
Mercury and mislabeling and bycatch, oh my! [Published Anchorage Daily News - 1 hour ago]
XL Group partners with Acheson to manage food s... [Published Individual.com - 1 hour ago]
AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) Long-T... [Published SBWire - 1 hour ago]
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Blogs

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Cochlear Receives FDA Approval of the Aqua+ Acc... [Published PR Newswire: Consumer Products & Retail - 41 mins ago]
CENTENNIAL, Colo., April 21, 2014 /PRNewswire/ -- Cochlear Limited (ASX: COH), the global leader in implantable hearing solutions, announced that the US Food and Drug Administration (FDA) has approved the Aqua+ accessory, the only waterproof behind-the-ear ...
Odds of Sarepta Drug Approval Rise Sharply [Published 24/7 Wall St. - 43 mins ago]
Shares of Sarepta Therapeutics went through the roof Monday morning following an announcement that it plans to have a New Drug Application filed with the FDA by the end of 2014 for its muscular... ...
Better Donor Transport - Organ Care System FDA ... [Published Scientific Blogging - Culture - 50 mins ago]
At the International Society for Heart and Lung Transplantation (ISHLT) 34th Annual Meeting in San Diego, TransMedics announced results of the PROCEED II heart transplant Food and Drug Administration (FDA) pivotal trial results using the Organ Care System ...
Sarepta to start new trials on muscle disorder ... [Published Yahoo! Health News - 2 hours ago]
(Reuters) - Sarepta Therapeutics Inc will start new trials of its experimental muscle disorder drug, nearly five months after the U.S. Food and Drug Administration said data from a previous study may not be sufficient to support the drug's app... ...
Study: Children Given Codeine in ER Despite Risks [Published TIME.com - 2 hours ago]
The painkiller codeine is prescribed to kids in at least half-a-million emergency room visits, a new study suggests , despite recommendations in place to limit its use among children. Only 3% of children’s ER trips in 2010 resulted in a codeine prescription, ...
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Audio/Video

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New at-home colon cancer test shows promising r... [Published Reuters Video: Top News - Mar 19 2014]
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Press Releases

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GSK and Genmab Receive FDA Approval for Arzerra... [Published GlobeNewswire: Acquisitions News - Apr 17 2014]
ALK announces FDA approval for Merck’s ragweed ... [Published GlobeNewswire: Acquisitions News - Apr 17 2014]
Galectin Therapeutics Announces First Patient D... [Published GlobeNewswire: Acquisitions News - Apr 17 2014]
ALK announces FDA approval for Merck’s grass su... [Published GlobeNewswire: Advertising News - Apr 14 2014]
Syneron Receives US FDA Clearance to Market the... [Published Financial Services - Apr 14 2014]
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