FDA News

FDA Approvals - FDA chief: Cuts threaten drug approvals Lorraine McCartin s breast cancer

2013-04-01T09:45:55Z

FDA chief: Cuts threaten drug approvals
Lorraine McCartin s breast cancer has been in remission for more than a year, thanks to a drug called Kadcyla that the Food and Drug Administration only recently approved solely for patients with late-stage breast cancer. In 2010, McCartin, 56, of Hanson was able to get access to the drug only by flying to Virginia every three weeks as part of a clinical trial, an expense a friend who also had ...

Biotech Industry Soars in 2012 as FDA Drug Approvals Reach a 15-Year High
A sharp increase in drug approvals and mergers and acquisitions combined to create a bull market for the Biotechnology Industry in 2012. The iShares NASDAQ Biotechnology Index , the SPDR S&P Biotech ETF ...

FDA 's New "Breakthrough" Designation Allows New Drugs to Gain Approval After Just 1 Round of Testing
Programs developed by the U.S. Food and Drug Administration to speed up the approval process has been a major driver for growth within the Biotech Industry. In 2012, FDA drug approvals totaled a 15-year ...

FDA approves Lymphoseek to help locate lymph nodes in patients

2013-04-01T01:35:50Z

FDA approves Lymphoseek to help locate lymph nodes in patients with certain cancers
The U.S. Food and Drug Administration today approved Lymphoseek (technetium Tc 99m tilmanocept) Injection, a radioactive diagnostic imaging agent that helps doctors locate lymph nodes in patients with breast cancer or melanoma who are undergoing surgery to remove tumor-draining lymph nodes.

FDA approves Osphena for postmenopausal women experiencing pain during sex

2013-04-01T00:55:48Z

FDA approves Osphena for postmenopausal women experiencing pain during sex
The U.S. Food and Drug Administration today approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause.

Titan Pharma: FDA Panel Live Blog Titan Pharma FDA Panel

2013-03-31T22:45:49Z

Titan Pharma: FDA Panel Live Blog
Titan Pharma FDA Panel Live Blog BETHESDA, Md. (TheStreet) -- An FDA advisory panel will spend Thursday reviewing a long-acting treatment for opioid addiction from Titan Pharmaceuticals . The panel is expected to be contentious because FDA 's own reviewers expressed doubts about the ability of Titan's drug, known as Probuphine, to adequately curb addiction. The FDA 's concerns, made public in a ...

Quidel and Life Technologies Receive FDA Clearance for Clostridium difficile Assay and QuantStudio Dx and 7500 Fast ...
SAN DIEGO and CARLSBAD, Calif., March 18, 2013 /PRNewswire/ -- Quidel Corporation (NASDAQ: QDEL) and Life Technologies Corporation (NASDAQ: LIFE) announced today that they received 510(k) clearances from ...

Quidel and Life Technologies Receive FDA Clearance for Clostridium difficile Assay and Quantstudio(TM) DX and 7500 ...
Quidel Corporation and Life Technologies Corporation announced today that they received 510 clearances from the United States Food and Drug Administration to market the Quidel Molecular Direct C. difficile ...

FDA Approvals - FDA Approves Novartis' TOBI Podhaler Novartis AG's TOBI Podhaler (tobramycin

2013-03-31T12:00:45Z

FDA Approves Novartis' TOBI Podhaler
Novartis AG's TOBI Podhaler (tobramycin inhalation powder) recently received US FDA approval for the treatment of bacterial lung infection in cystic fibrosis patients caused by the Pseudomonas aeruginosa ...

FDA chief: Cuts threaten drug approvals
Lorraine McCartin s breast cancer has been in remission for more than a year, thanks to a drug called Kadcyla that the Food and Drug Administration only recently approved solely for patients with late-stage breast cancer. In 2010, McCartin, 56, of Hanson was able to get access to the drug only by flying to Virginia every three weeks as part of a clinical trial, an expense a friend who also had ...

Biotech Industry Looks to Benefit From FDA 's New "Breakthrough" Designation
Programs developed by the U.S. Food and Drug Administration to speed up the approval process has been a major driver for growth within the Biotech Industry. In 2012, FDA drug approvals totaled a 15-year ...

FDA alerts health care providers of recall of all sterile

2013-03-31T08:10:43Z

FDA alerts health care providers of recall of all sterile drug products by Med Prep Consulting in New Jersey
The U.S. Food and Drug Administration is alerting health care providers and patients of a voluntary nationwide recall of all lots of all products produced by Med Prep Consulting Inc. of Tinton Falls, N.J, a specialty pharmacy licensed by the State of New Jersey. The recall was announced after health care providers at a hospital in Connecticut observed floating particles, later identified to be a fungus, in five bags of magnesium sulfate intravenous solution.

Implantable Drug Delivery Devices Market is Expected to Reach USD

2013-03-31T08:05:42Z

Implantable Drug Delivery Devices Market is Expected to Reach USD 21.1 Billion Globally in 2018: Transparency Market ...
ALBANY, New York, March 4, 2013 /PRNewswire/ --According to a new market report published by Transparency Market Research ( http://www.transparencymarketresearch.com ), "Implantable Drug Delivery ...

Global Contraceptives Industry
NEW YORK, March 19, 2013 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue: Global Contraceptives Industry http://www.reportlinker.com/p087292/Global-Contraceptives-Industry.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Drug_and_MedicationThis ...

Clinical Specialties Issues Voluntary Nationwide Recall of Avastin Unit Dose

2013-03-31T07:00:41Z

Clinical Specialties Issues Voluntary Nationwide Recall of Avastin Unit Dose Syringes due to Potential Serious Eye Infection
Clinical Specialties is voluntarily recalling Avastin unit dose syringes. The product has or potentially could result in an infection within the eye.

Lifestyle Evolution Inc. (LEI), Issues Allergy Alert -- -Undeclared Milk in Lifestyle Evolution Inc. s, NuGO FREE, NuGO Dark and NuGO Slim Non Dairy bars
Lifestyle Evolution Inc announces the voluntary recall of NuGO FREE, NuGO Dark and NuGO Slim Non Dairy bars Made BEFORE October 2012 because of the potential for undeclared milk.

Daesang Issues Allergy Alert on Undeclared Peanuts in Mixed Soy Bean Paste (Sesame and Garlic)
March 19, 2013 - Daesang America Inc. One University Plaza, Suite 603, Hackensack, NJ 07601 is recalling its 500gram (17.64 Ounce) packages of Sesame and Garlic flavored Mixed Soy Bean Paste because they may contain undeclared peanuts. People who have allergies to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA Approvals - Biotech Industry Soars in 2012 as FDA Drug Approvals Reach

2013-03-30T14:30:33Z

Biotech Industry Soars in 2012 as FDA Drug Approvals Reach a 15-Year High
A sharp increase in drug approvals and mergers and acquisitions combined to create a bull market for the Biotechnology Industry in 2012. The iShares NASDAQ Biotechnology Index , the SPDR S&P Biotech ETF ...

Programs by the FDA Designed to Speed Up Approval Process for Critical Drugs a Key Factor in Biotech's Industry Success
Programs developed by the U.S. Food and Drug Administration to speed up the approval process has been a major driver for growth within the Biotech Industry. In 2012, FDA drug approvals totaled a 15-year ...

FDA Approves Novartis' TOBI Podhaler
Novartis AG's TOBI Podhaler (tobramycin inhalation powder) recently received US FDA approval for the treatment of bacterial lung infection in cystic fibrosis patients caused by the Pseudomonas aeruginosa ...

FDA approves Osphena for postmenopausal women experiencing pain during sex

2013-03-30T01:35:27Z

FDA approves new silicone breast implant The U.S. Food and

2013-03-30T00:55:27Z

FDA approves new silicone breast implant
The U.S. Food and Drug Administration today approved the Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant to increase breast size (augmentation) in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age. Natrelle 410 implants are manufactured by Allergan, Inc.

Quidel and Life Technologies Receive FDA Clearance for Clostridium difficile

2013-03-29T22:45:26Z

Quidel and Life Technologies Receive FDA Clearance for Clostridium difficile Assay and Quantstudio(TM) DX and 7500 ...
Quidel Corporation and Life Technologies Corporation announced today that they received 510 clearances from the United States Food and Drug Administration to market the Quidel Molecular Direct C. difficile ...

Titan Pharmaceuticals Announces FDA Advisory Committee Recommends Approval of Probuphine for the Treatment of Adult ...
Titan Pharmaceuticals, Inc. today announced that the majority of Psychopharmacologic Drugs Advisory Committee of the U.S. Food and Drug Administration members recognized the favorable benefit-risk profile ...

FDA Approvals - Sharp Increase in FDA Drug Approvals a Major Factor in

2013-03-29T19:20:24Z

FDA Approvals - Sharp Increase in FDA Drug Approvals a Major Factor in

2013-03-28T19:20:13Z

Sharp Increase in FDA Drug Approvals a Major Factor in Biotech Industry's Success in 2012
A sharp increase in drug approvals and mergers and acquisitions combined to create a bull market for the Biotechnology Industry in 2012. The iShares NASDAQ Biotechnology Index , the SPDR S&P Biotech ETF ...

FDA chief: Sequester cuts threaten drug approvals
The head of the FDA told about 400 biotechnology leaders last week that the federal agency is working to expedite the approval of safe new drugs, but across-the-board federal budget cuts threaten to hamper its efforts. Commissioner Margaret Hamburg said she is hoping Congress will enable the FDA to access user fees the industry pays for the agency's operating expenses.

Pernix Therapeutics Receives FDA Approvals
Pernix Therapeutics Holdings, Inc. ( Pernix or the Company ), a specialty pharmaceutical company, recently announced that its subsidiary, Hawthorn Pharmaceuticals, Inc., has received U.S. Food and Drug Administration ( FDA ) approval of a new drug application (NDA) for VITUZ Oral Solution (hydrocodone bitartrate and chlorpheniramine maleate)

FDA approves TOBI Podhaler to treat a type of bacterial

2013-03-28T08:10:08Z

FDA approves TOBI Podhaler to treat a type of bacterial lung infection in cystic fibrosis patients
The U.S. Food and Drug Administration today approved TOBI Podhaler (tobramycin inhalation powder) for the management of cystic fibrosis patients with Pseudomonas aeruginosa, a bacterium that causes lung infections.