FDA Food & Drug Administration

Type: Organization
Name: FDA Food & Drug Administration (Food and Drug Administration, FDA, Federal Drug Administration)
First reported 18 hours ago - Updated 1 hour ago - 11 reports

US approves first vaccine against dangerous meningitis strain

By | IANS India Private Limited/Yahoo India News – 10 minutes agoControversial sovereign fund 1Malaysia Development Berhad (1MDB) today sought to clear the air over "unsubstantiated" claims of shadowy dealings, preferential treatment and exorbitant debt ... [Published Yahoo! Malaysia - 3 hours ago]
First reported 17 hours ago - Updated 1 hour ago - 5 reports

Whiskey pulled over antifreeze ingredient, but not in U.S.

One of the fastest-growing liquor brands in America is being recalled in Europe over an ingredient found in some types of antifreeze.But here in America, it's still on store shelves, CBS News' Vinita Nair reports."Whiskey is hot, but flavored whiskey ... [Published CBS News - 1 hour ago]
First reported 5 hours ago - Updated 1 hour ago - 9 reports

U.S. FDA Approves Once-Daily XIGDUO™ XR Tablets for Adults with Type 2 Diabetes

WILMINGTON, Del.--(EON: Enhanced Online News)--AstraZeneca (NYSE:AZN) today announced that the U.S. Food and Drug Administration has approved once-daily XIGDUO™ XR (dapagliflozin and metformin hydrochloride extended-release) for the treatment of adults ... [Published EON Science - 1 hour ago]
First reported 12 hours ago - Updated 4 hours ago - 4 reports

The FDA Warning on Antidepressants and Suicidality — Why the Controversy?

The controversy over the decision by the Food and Drug Administration (FDA) in late 2004 to require a boxed warning on antidepressants regarding the risk of suicidality in children and adolescents reached a crescendo in 2007 with the publication of a ... [Published New England Journal of Medicine - 4 hours ago]
First reported 4 hours ago - Updated 4 hours ago - 3 reports

TWi Pharmaceuticals Receives US FDA Approval on Generic Donepezil Hydrochloride Tablets USP, 23 mg, its fifth ANDA from US FDA

TWi Pharmaceuticals is preparing to launch the product in the US via its fully owned subsidiary, TWi Pharmaceuticals USAAccording to IMS Health, US sales of Aricept® 23mg were approximately $78 millionAbout TWi Pharmaceuticals, Inc. TWi Pharmaceuticals, ... [Published Industrial Info Financials - 4 hours ago]
First reported Oct 29 2014 - Updated 6 hours ago - 3 reports

FDA update on supplement/drug interactions

What should we know about taking supplements with medications? We should know it is potentially unhealthy. The Food and Drug Administration has issued a consumer update warning of the potential interactions between medications and dietary supplements. ... [Published Brownfield Network - 6 hours ago]
First reported 18 hours ago - Updated 7 hours ago - 17 reports

1st vaccine for deadly form of meningitis approved

WASHINGTON — When meningitis outbreaks sickened students at Princeton and the University of California at Santa Barbara last year, the schools had to seek special permission to vaccinate their students, using a vaccine that was not yet approved for use ... [Published Pittsburgh Tribune Review - 10 hours ago]
First reported Oct 28 2014 - Updated 15 hours ago - 3 reports

FDA cautions against 'undeclared' food allergens

(HealthDay)—Some food labels may not reliably list all possible food allergens, according to the U.S. Food and Drug Administration. The agency added that these "undeclared allergens" are the leading cause of FDA-requested food recalls.To prevent these ... [Published Medical Xpress - 15 hours ago]
First reported 17 hours ago - Updated 17 hours ago - 5 reports

Trace One Solutions Enable Compliance of Proposed FDA Food Safety Modernization Act (FSMA) Guidelines

Trace One , a global leader in private label, product lifecycle management (PLM) solutions and software for retailers, manufacturers and suppliers, supports the U.S. Food and Drug Association (FDA) revised…Click to Continue » ... [Published Fort Mills Times - 17 hours ago]
First reported Oct 29 2014 - Updated 20 hours ago - 7 reports

FDA grants orphan drug status to Glassia for GVHD

The FDA granted orphan drug designation to a liquid alpha-1 proteinase inhibitor for the treatment of patients with graft-versus-host disease following allogeneic bone marrow stem cell transplant, its manufacturer announced recently.Based on preclinical ... [Published Orthopedics Today - 20 hours ago]
First reported Oct 28 2014 - Updated 22 hours ago - 4 reports

FDA Approves Baxter's Obizur For Acquired Hemophilia A

By Cyndi RootPatients with acquired hemophilia A (AHA), a rare bleeding disorder, have a new treatment, as the Food and Drug Administration (FDA) has approved Baxter’s Obizur. Baxter announced the approval in a press release , stating that the Antihemophilic ... [Published Bioresearch Online - 22 hours ago]
First reported Oct 28 2014 - Updated Oct 28 2014 - 5 reports

U.S. FDA Issues Emergency Authorization for Two New Ebola Tests

Reuters Health InformationYasmeen AbutalebOctober 28, 2014Oct 25 (Reuters) - Federal health regulators granted emergency authorization on Saturday for two new tests made by BioFire Defense that detect Ebola in humans, highlighting new steps by the government ... [Published General Medicine eJournal - Oct 28 2014]

Quotes

"We are pleased that after reviewing our dataset the FDA recognizes that NBI-98854 is potentially an important therapy for the treatment of tardive dyskinesia, and we look forward to working closely with the Division of Psychiatry to advance our development program" said Christopher F O'Brien, Chief Medical Officer of Neurocrine Biosciences
"Most consumers are not given enough information," she said. "If consumers don't speak up that they want more information about what they're eating, nobody is going to know that they care."
Dvorak continued, "Our two companies will be stronger together, and that is proven by the management team we have assembled.  With the help of these individuals, and many more across both organizations, we are making great progress in our integration planning and are positioned to immediately begin capturing the benefits of the combination upon closing.  I also want to recognize all of our leaders for their continued guidance as we plan for the new Zimmer Biomet and thank those who will be continuing in advisory roles following the closing to help ensure a seamless transition and integration."
"We are hopeful that in the next year, the results of this trial will show this drug has a positive impact on enrolled patients and also that it will have implications for patients with other forms of intractable epilepsy" said Dr. Gary Clark, chief of neurology at Texas Children's, professor of pediatrics and section chief of pediatric neurology and developmental neuroscience...

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All (15865) | News (14450) | Reports (0) | Blogs (1301) | Audio/Video (3) | Fact Sheets (12) | Press Releases (66)
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Neurocrine Biosciences' NBI-98854 drug gets bre... [Published News-Medical.Net - 6 mins ago]
SurgaColl Aims to Fix Your Bones and Joints Wit... [Published Xconomy - 7 mins ago]
RetroSense Therapeutics Granted Orphan Drug Des... [Published Fort Mills Times - 23 mins ago]
Garcinia Cambogia Allows you to Burn off 3 to 5... [Published Newton Abbot People - 25 mins ago]
30% of shrimp products misrepresented, study says [Published CNN - 26 mins ago]
Zimmer Announces Executive Leadership Team and -2- [Published Scottrade - 33 mins ago]
RetroSense Therapeutics Granted Orphan Drug Des... [Published 4 Traders - 35 mins ago]
Novo Nordisk more cautious on timing of U.S. Tr... [Published Yahoo! Canada - 41 mins ago]
When it comes to investing, the eye has it [Published Health Business Blog - 42 mins ago]
Gilead Dips On Missing Sovaldi Sales Estimates;... [Published Bidness Etc - 43 mins ago]
Why You Shouldn't Worry About Gilead Sciences, ... [Published Motley Fool Discussion Boards - 43 mins ago]
Zimmer Announces Executive Leadership Team and ... [Published 35 WSEE - 43 mins ago]
Texas Children's Hospital : part of first world... [Published 4 Traders - 47 mins ago]
Zimmer Announces Executive Leadership Team and ... [Published ADVFN UK - 47 mins ago]
Novo Nordisk more cautious on timing of U.S. Tr... [Published Reuters UK - 57 mins ago]
Cortendo Announces HealthCap Leads $11M (NOK 73... [Published Scottrade - 57 mins ago]
Garcinia Cambogia Extra Immense Power to Burn B... [Published St Neots People - 1 hour ago]
NCI supports further clinical development of ne... [Published News-Medical.Net - 1 hour ago]
Grass Pollen Allergy Market - Global Industry A... [Published MyNewsDesk - 1 hour ago]
Food's Latest Scandal: What's Wrong With Your S... [Published Forbes.com - 1 hour ago]
Neurocrine Biosciences Receives Breakthrough Th... [Published Pettinga Financial Advisors - 1 hour ago]
POZEN Announces November 6th Webcast of Third Q... [Published Industrial Info Financials - 1 hour ago]
Frontrunning: October 30 [Published Zero Hedge - 1 hour ago]
Whiskey pulled over antifreeze ingredient, but ... [Published CBS News - 1 hour ago]
Revive submits IND application for REV-002 [Published Stockwatch - 1 hour ago]
Advaxis's ADXS-cHER2 Immunotherapy Demonstrates... [Published A.M. Best - 1 hour ago]
Neurocrine Biosciences Receives Breakthrough Th... [Published PR Newswire: General Business - 1 hour ago]
CeloNova's Super-selective Embolic Microsphere ... [Published Business Wire Health News - 1 hour ago]
Glenmark Pharma Q2 net profit at Rs1650.78 mn [Published India Infoline - 1 hour ago]
Dendreon And CMS Under SEC Scrutiny Over Inside... [Published Bidness Etc - 1 hour ago]
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Blogs

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When it comes to investing, the eye has it [Published Health Business Blog - 42 mins ago]
This is a guest post by life sciences entrepreneur Mikael Totterman Eye on investing I was surprised by a recent Wall Street Journal article, which reported that venture capitalists are now investing more in the eyes than in any other organ . ...
Frontrunning: October 30 [Published Zero Hedge - 1 hour ago]
"Soaring consumer confidence" - How the Economy Is Stoking Voter Anger at Incumbent Governors ( WSJ ) Euro zone deflation worries shield German Bunds from upbeat Fed ( Reuters ) Greece’s Euro Dilemma Is Back as Minister Sees Volatility ( BBG ) Ukraine ...
Neurocrine Biosciences Receives Breakthrough Th... [Published PR Newswire: General Business - 1 hour ago]
SAN DIEGO, Oct. 30, 2014 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for its Vesicular Monoamine Transporter 2 inhibitor, ...
CeloNova's Super-selective Embolic Microsphere ... [Published Business Wire Health News - 1 hour ago]
SAN ANTONIO--(BUSINESS WIRE)--CeloNova BioSciences announces FDA approval to start IDE clinical trial for its novel ONCOZENE™ embolic microspheres, loaded with doxorubicin, a chemotherapy drug used in the treatment of HCC. ...
U.S. FDA Approves Once-Daily XIGDUO™ XR Tablets... [Published EON Science - 1 hour ago]
WILMINGTON, Del.--(EON: Enhanced Online News)--AstraZeneca (NYSE:AZN) today announced that the U.S. Food and Drug Administration has approved once-daily XIGDUO™ XR (dapagliflozin and metformin hydrochloride extended-release) for the treatment of adults ...
1 2 3 4 5 6 7 8 9 10 ...

Audio/Video

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The FDA Approves An Expensive New Hepatitis Drug [Published Wall Street Journal What's News - Oct 10 2014]
Is Siberia a Safe Place for Smallpox? [Published Slate Magazine - Jul 15 2014]
The Persistent Danger of Poxes [Published Slate Magazine - Jul 11 2014]
1

Press Releases

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US FDA APPROVES ONCE-DAILY XIGDUO™ XR TABLETS [Published GlobeNewswire: Acquisitions News - 5 hours ago]
U.S. FDA Grants Fast Track Designation to Novav... [Published GlobeNewswire: Acquisitions News - 15 hours ago]
GLG Announces FDA's Issuance of Letter of No Ob... [Published GlobeNewswire: Acquisitions News - Oct 27 2014]
Burzynski Research Institute, Inc. Announces FD... [Published Financial Services - Oct 24 2014]
Rich Pharmaceuticals Announces Submission of In... [Published GlobeNewswire: Acquisitions News - Oct 23 2014]
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