FDA Food & Drug Administration

Type: Organization
Name: FDA Food & Drug Administration (Food and Drug Administration, FDA, Federal Drug Administration)
First reported 8 hours ago - Updated 54 mins ago - 2 reports

Parents Beware! Ads for Concussion Supplements

Dietary supplement companies are tuned into the concerns parents have about their children and sports related concussions. They often promise that their supplements provide faster brain healing and less time spent away from sport activities.The U.S. Food ... [Published ConchoValleyHomepage.com - 54 mins ago]
First reported 7 hours ago - Updated 1 hour ago - 2 reports

Creation of investment ombudsman to strengthen business confidence – DTI

Share this:The Department of Trade and Industry (DTI) cited the creation of the investment ombudsman team as an innovation that will further boost investments in the Philippines, strengthen investor confidence and build an enabling business environment ... [Published Manila Bulletin - 1 hour ago]
First reported 6 hours ago - Updated 1 hour ago - 4 reports

7,500+ cases of Kraft Singles recalled

NORTHFIELD, Ill. — Kraft Foods Group is recalling 7,691 cases of Kraft American Singles because one of the ingredients was stored at the incorrect temperature and they could spoil before their expiration date.According to a release from the Food and Drug ... [Published Fox17 - 3 hours ago]
First reported 10 hours ago - Updated 2 hours ago - 2 reports

Takeda to submit data for pioglitazone containing medicines including ACTOS

Takeda Pharmaceutical Company Limited announced the completion of the post-marketing commitment and submissions of data from a 10-year epidemiology study to regulatory authorities including the United States (U.S.) Food and Drug Administration (FDA), ... [Published Hospital Pharmacy Europe - 2 hours ago]
First reported 15 hours ago - Updated 8 hours ago - 3 reports

FDA approves UCB's Vimpat as monotherapy

UCB has been boosted by the news that regulators in the USA have approved a supplemental New Drug Application for its epilepsy treatment Vimpat to be used as monotherapy.Specifically, the US Food and Drug Administration has given the green light to Vimpat ... [Published Pharma Times - 8 hours ago]
First reported Aug 31 2014 - Updated 9 hours ago - 17 reports

Wockhardt Ltd soars after receiving QIDP status for two drugs

.. Wockhardt Ltd BSE 3.72 % went up to 6.2 per cent in exchange on Monday, after the pharma major said that its new medication revelation program in hostile to infective exploration and has gotten a real help after two of its medications, WCK 771 and ... [Published TopNews United States - 9 hours ago]
First reported 11 hours ago - Updated 11 hours ago - 2 reports

FDA approves InnoPharma's decitabine for injection to treat myelodysplastic syndromes

The US Food and Drug Administration (FDA) has granted approval to InnoPharma's abbreviated new drug application (ANDA) for decitabine for injection. ... [Published PBR - News - 11 hours ago]
First reported 15 hours ago - Updated 12 hours ago - 6 reports

Natco's US marketing partner files ANDA for 'Copaxone'

Natco Pharma's marketing partner in the USA, Mylan Inc., has filed an Abbreviated New Drug Application (ANDA) for a three-times-a-week generic COPAXONE (glatiramer acetate injection, 40 mg/mL) and has been accepted by the US Food and Drug Administration ... [Published Indian-Commodity - 12 hours ago]
First reported Aug 31 2014 - Updated 23 hours ago - 2 reports

Kraft Recalls Thousands of Cases of American Singles Cheese

Kraft voluntarily recalled some of its Singles American cheese products after an ingredient was not stored properly.Kraft Foods Group has voluntarily recalled nearly 8,000 cases of some of its popular American Singles cheese product amid spoilage concerns, ... [Published KTLA - Aug 31 2014]
First reported Aug 31 2014 - Updated Aug 31 2014 - 2 reports

Defendant Dismissed from Pennsylvania Vaginal Mesh Lawsuits, Bernstein Liebhard LLP Reports

Secant Medical LLC, a manufacturer of polypropylene mesh used in pelvic mesh implants, has been dismissed from hundreds of vaginal mesh lawsuits (http://www.transvaginalmeshlawsuithelp.com/)pending in a mass tort litigation underway in Pennsylvania’s ... [Published Bio-Medicine - Aug 31 2014]
First reported Aug 30 2014 - Updated Aug 30 2014 - 2 reports

Natco Pharma’s partner Mylan files for Copaxone generic

An Abbreviated New Drug Application (ANDA) for three-times-a-week generic Copaxone (glatiramer acetate injection) filed by Mylan Inc has been accepted by the US Food and Drug Administration (US FDA).According to a released issued by Natco Pharma Ltd here ... [Published Hindu Business Line - Aug 30 2014]
First reported Aug 30 2014 - Updated Aug 30 2014 - 2 reports

With Androgel Lawsuits Pending and Safety of Testosterone Therapy Questioned by FDA, New Testosterone Drug Rivals Androgel

Androgel lawsuit news updates and lawsuit information is available from The Onder Law Firm at AndrogelTestosteroneLawsuitCenter.com. (PRWeb August 30, 2014) Read the full story at http://www.prweb.com/releases/Androgel-lawsuit/Androgel-testostero ... [Published Presskontakt.se - Aug 30 2014]

Quotes

"As we continue to work on this problem, we can't guarantee you won't see a claim about [traumatic brain injuries]," Coody said. "But we can promise you this: There is no dietary supplement that has been shown to prevent or treat them. If someone tells you otherwise, walk away."
"It is shown to have strong antiviral property against the Ebola virus" in the lab and in patients, the minister said as the Ebola outbreak continues to accelerate in West Africa with the death toll now estimated at 1,552...
...in 2010, Glaxo still has protections on the inhalers used to deliver it, and the US is making generic drug makers prove their devices are as good. "Generic Advair - if Cipla gets it through - will change the face of Cipla" Hamied said, without specifying when he expects to start selling his version in the US or if his company could be the first to do so
"The completion of this long-term study is a milestone in the history of ," said Tom Harris, head, global regulatory affairs, Takeda. "The results of the study provide reassurance with regard to the use of and the risk of bladder and further support the positive benefit risk profile of the product."

More Content

All (23195) | News (19115) | Reports (3) | Blogs (3767) | Audio/Video (5) | Fact Sheets (39) | Press Releases (186)
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Parents Beware! Ads for Concussion Supplements [Published ConchoValleyHomepage.com - 54 mins ago]
*Nigeria to receive experimental Ebola drug fro... [Published Saudi Press Agency - 1 hour ago]
Creation of investment ombudsman to strengthen ... [Published Manila Bulletin - 1 hour ago]
ALS and the ice bucket challenge [Published Philippine Star - 1 hour ago]
Wockhardt gets QIPD status for anti-infectives [Published Financial Chronicle - 1 hour ago]
Cipla targets US with Glaxo's Advair [Published Business Standard India - 2 hours ago]
Takeda to submit data for pioglitazone containi... [Published Hospital Pharmacy Europe - 2 hours ago]
Early Stage Minimally Invasive Candidate AD Bio... [Published PRWeb - 2 hours ago]
7,500+ cases of Kraft Singles recalled [Published Fox17 - 3 hours ago]
More research on medicinal marijuana [Published Sunraysia Daily - 3 hours ago]
FUJIFILM : Nigeria to receive experimental Ebol... [Published 4 Traders - 3 hours ago]
US FDA 2009 import ban legal NAFTA panel tells ... [Published In-Pharmatechnologist - 3 hours ago]
BigPharma manufacturers of addictive painkiller... [Published Sott.net - 3 hours ago]
EPOCH of Weston director: Understanding GMOs [Published Wicked Local Wayland - 3 hours ago]
BIR lists VAT-exempt livestock feed ingredients [Published Business World - 3 hours ago]
Ipsen receives priority review for sNDA for Som... [Published Pharma Letter - 3 hours ago]
Mexico first country to launch Novo Nordisk’s R... [Published Pharma Letter - 3 hours ago]
FDA increases cilantro sampling after Cyclospor... [Published Food Quality News - 3 hours ago]
Nonfoods Talk: Fun in the sun [Published GroceryHeadquarters.com - 4 hours ago]
Creation of Investment Ombudsman Team seen to s... [Published Philippine Star - 4 hours ago]
“For human or not for human” [Published Business World - 4 hours ago]
Outsourcing up for GMP APIs as Onyx completes m... [Published Outsourcing Pharma - 4 hours ago]
Idelalisib: First-in-class oral therapy targets... [Published Pharmacist.com - 4 hours ago]
Hot flashes: Nonhormonal therapies work as well... [Published Pharmacist.com - 4 hours ago]
Three initiatives focus on safe use of acetamin... [Published Pharmacist.com - 4 hours ago]
APhA to FDA: More research needed on e-cigarettes [Published Pharmacist.com - 4 hours ago]
Showcase, September 2014 [Published Pharmacist.com - 4 hours ago]
Combating opioid drug abuse with naloxone [Published Pharmacist.com - 4 hours ago]
Empagliflozin: Once-daily oral treatment for ty... [Published Pharmacist.com - 4 hours ago]
Opioid epidemic: Abuse-deterrent opioids the an... [Published Pharmacist.com - 4 hours ago]
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Blogs

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Takeda completes post-marketing commitment to s... [Published PBR - News - 10 hours ago]
Takeda Pharmaceutical (Takeda) has completed the post-marketing commitment and submissions of data from a 10-year epidemiology study to regulatory authorities including the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and ...
FDA grants QIDP status for Wockhardt anti-infec... [Published PBR - News - 11 hours ago]
Wockhardt Limited has announced a major boost to the New Drug Discovery program in Anti-Infective research when two of its drugs, WCK 771 and WCK 2349, received the coveted Qualified Infectious Disease Product (QIDP) status from U.S. Food & Drug Administration ...
FDA approves InnoPharma's decitabine for inject... [Published PBR - News - 11 hours ago]
The US Food and Drug Administration (FDA) has granted approval to InnoPharma's abbreviated new drug application (ANDA) for decitabine for injection. ...
New indication for VIMPAT® (lacosamide): UCB's ... [Published PR Newswire: Policy & Public Interest - 15 hours ago]
BRUSSELS, Sept. 1, 2014 /PRNewswire/ -- 0700 (CEST) – regulated information -- UCB announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for VIMPAT® (lacosamide) C-V as monotherapy in ...
Ipsen Announces Acceptance of Filings for Somat... [Published Business Wire Health News - 15 hours ago]
PARIS--(BUSINESS WIRE)--Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review of its supplemental New Drug Application (sNDA) for Somatuline® Depot® ...
1 2 3 4 5 6 7 8 9 10 ...

Audio/Video

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FDA shift fuels Tekmira's stock [Published Reuters Video: Business - Aug 08 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]
FDA Reviewing Psychiatric Side Effects of Chantix [Published Wall Street Journal What's News - Apr 25 2014]
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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Momenta Pharmaceuticals Announces Abbreviated N... [Published GlobeNewswire: Advertising News - Aug 28 2014]
OncoMed Pharmaceuticals Announces Removal of Pa... [Published GlobeNewswire: Acquisitions News - Aug 28 2014]
RedHill Biopharma Provides Update on Expansion ... [Published GlobeNewswire: Acquisitions News - Aug 27 2014]
FDA Approves Genzyme’s Cerdelga™ (eliglustat) C... [Published Genzyme Press Release - Aug 19 2014]
Vital Images, Inc. Receives 510(k) Clearance fo... [Published GlobeNewswire: Acquisitions News - Aug 18 2014]
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