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GW Pharmaceuticals Receives Orphan Drug Designation For Cannabidiol Treatment of Neonatal Hypoxic-Ischemic Encephalopathy

April 24, 2015 11:15 am | by Globe Newswire | News | Comments

There are currently no FDA-approved medicines specifically indicated for NHIE.

Hospira Recalls One Lot Of Bupivacaine HCl Injection

April 24, 2015 11:02 am | by U.S. Food And Drug Administration | News | Comments

Hospira is issuing a voluntary recall of one lot of Preservative-Free Bupivacaine HCl Injection...

Capricor Granted FDA Orphan Drug Designation For Allogeneic Cardiosphere-Derived Cells

April 22, 2015 11:28 am | News | Comments

Capricor Therapeutics, Inc. today announced that it has been granted orphan drug designation by...

Glaxo Recalls Flu Vaccine Due to Potency Problem

April 17, 2015 3:37 pm | by MATTHEW PERRONE, AP Health Writer | News | Comments

The company alerted U.S. customers Tuesday that the vaccine can lose potency and fail to...

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Survey: More Than Half of Older Adults in The US Now Taking Aspirin

April 17, 2015 3:05 pm | by Oregon State University | News | Comments

More than half of the older adults in the United States are now taking a daily dose of aspirin, even though its use is not recommended by the Food and Drug Administration for most people who have not yet had a heart attack or stroke.

FDA Approves First Generic To Treat MS

April 17, 2015 12:16 pm | by FDA | News | Comments

The U.S. Food and Drug Administration today approved the first generic version of Copaxone (glatiramer acetate injection), used to treat patients with relapsing forms of multiple sclerosis (MS).

U.S. Marshals Seize Unapproved Drugs From Florida Distributor

April 16, 2015 3:31 pm | by FDA.gov | News | Comments

Stratus Pharmaceuticals marketed and distributed unapproved prescription drug products that were manufactured by Sonar Products, Inc., of Carlstadt, New Jersey.

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OriGen Biomedical Issues Nationwide Recall

April 16, 2015 11:20 am | by OriGen Biomedical | News | Comments

OriGen Biomedical initiated a nationwide recall for one lot of Reinforced Dual Lumen ECMO catheters.

FDA Warns of Liver Injury From Muscle-Building Supplement

April 14, 2015 2:05 pm | by MATTHEW PERRONE, AP Health Writer | News | Comments

The Food and Drug Administration is warning consumers to avoid dietary supplements sold by a Las Vegas company because they may contain anabolic steroids that can cause liver damage.

FDA Confirms Change of Ownership of 23 US Generic Drugs

April 13, 2015 3:54 pm | by PR Newswire | News | Comments

IDT Australia Limited announced that the U.S. Food and Drug Administration (FDA) has confirmed receipt of the change of ownership letters formally transferring ownership of the 23 generic drug products to IDT.

Big Retailers Pull Sales of Weight-Loss Supplements With Dangerous Chemical

April 10, 2015 3:30 pm | by Meagan Parrish, Editor, Chem.Info | News | Comments

The issue also intensified criticisms of the FDA.

Tekmira to Resume Ebola Drug Trials

April 10, 2015 12:00 pm | by Tekmira Pharmaceuticals | News | Comments

The FDA has notified Tekmira that the partial clinical hold on TKM-Ebola has been modified. Tekmira plans to resume the TKM-Ebola Phase I clinical trial in the coming weeks.

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Botox Death Prompts Lawsuit

April 10, 2015 11:48 am | by Ray Chester, McGinnis Lochridge LLP | News | Comments

Parents of Melinda Ann "Mandy" Fortuna filed suit yesterday against Allergan, Inc., alleging that a series of off-label Botox overdoses were responsible for their daughter's death.

Baxter Recalls IV Solutions

April 10, 2015 11:42 am | by Baxter International | News | Comments

Baxter International Inc. announced today it is voluntarily recalling select lots of IV solutions to the hospital/user level due to the potential presence of particulate matter.

Fast Track for BioBlast Pharma

April 9, 2015 11:53 am | by BioBlast Pharma | News | Comments

The FDA has granted Fast Track designation to BioBlast's Cabaletta for the treatment of patients with Oculopharyngeal Muscular Dystrophy (OPMD).

Prolong Flagship Product Granted Orphan Drug Designation

April 8, 2015 10:57 am | by Prolong Pharmaceuticals | News | Comments

Prolong Pharmaceuticals, LLC, a biopharmaceutical company, announced that the FDA has granted Orphan Drug Designation for its Sickle Cell Disease (SCD) treatment.

FDA Questions Evidence for Lower-Risk Tobacco Product

April 8, 2015 10:48 am | by Matthew Perrone, AP Health Writer | News | Comments

U.S. health regulators have questions about tobacco maker Swedish Match's bid to become the first to market a smokeless tobacco product as less harmful than cigarettes.

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Hospira gets FDA Warning

April 7, 2015 4:17 pm | by AP | News | Comments

Drug and medical device maker Hospira said that it received a warning letter from the FDA following an Italian factory inspection. The agency said it found problems with procedures that are supposed to prevent sterile products from being contaminated, and found fault with Hospira's inspections procedures. It also said the company should have better security protecting data generated during its manufacturing process.

Asia Agencies Purchase U.S. Simulation Software

April 6, 2015 12:01 pm | by Simulations Plus | News | Comments

Simulations Plus announced that several regulatory agencies around the world have added licenses of software for pharmaceutical discovery and development within the past three months.

FDA to Scrutinize Unproven Alternative Remedies

March 26, 2015 3:23 pm | by MATTHEW PERRONE, AP Health Writer | News | Comments

Federal officials plan to review the safety and evidence behind alternative remedies like Zicam and Cold-Eeze, products that are protected by federal law, but not accepted by mainstream medicine.

Science, Patients Driving Rare Disease Drug Research Surge

March 25, 2015 2:24 pm | by LINDA A. JOHNSON, AP Business Writer | News | Comments

The global pharmaceutical industry is pouring billions of dollars into developing treatments for rare diseases, which once drew little interest from major drugmakers but now point the way toward a new era of innovative therapies and big profits.

FDA Approves Sanofi Pasteur’s Quadracel DTaP-IPV Vaccine for Children

March 25, 2015 12:24 pm | News | Comments

Sanofi Pasteur, the vaccines division of Sanofi announced that FDAhas approved use of Quadracel vaccine for active immunization against diphtheria, tetanus, pertussis and poliomyelitis in children 4 through 6 years of age.

Emergent BioSolutions Receives FDA Approval for Anthrasil

March 25, 2015 11:40 am | News | Comments

Emergent BioSolutions has announced that the FDA has approved Anthrasil™ [Anthrax Immune Globulin Intravenous (Human)], also known as AIGIV, for treatment of inhalational anthrax in combination with appropriate antibacterial drugs.

FDA Approves New Treatment for Diabetic Retinopathy in Patients with Diabetic Macular Edema

March 25, 2015 11:31 am | News | Comments

The FDA has expanded the approved use for Eylea (aflibercept) injection to treat diabetic retinopathy in patients with diabetic macular edema.

FDA Warns Cosmetics Companies Against Promises That 'Go Too Far'

March 24, 2015 8:04 am | by Andy Szal, Digital Reporter | News | Comments

The agency said its tracking of claims by cosmetics companies during recent years indicated a proliferation in drugs claims--defined by the FDA as "intended to treat or prevent disease, or change the body’s structure or functions"--on product packaging and in web advertising.

FDA Panel Backs Glaxo Inhaler for Adults, Not Adolescents

March 20, 2015 8:39 am | by MATTHEW PERRONE, AP Health Writer | News | Comments

Government health advisers say a once-a-day respiratory inhaler from GlaxoSmithKline appears safe and effective for adults with asthma, but not for adolescents.

Vertex Gets FDA Approval of KALYDECO® for Children with Cystic Fibrosis

March 18, 2015 3:54 pm | News | Comments

Vertex Pharmaceuticals has announced that the FDA approved KALYDECO® for use in children ages 2 to 5 with cystic fibrosis (CF) who have one of 10 mutations in the cystic fibrosis transmembrane conductance regulator ( CFTR) gene.

Actavis Receives FDA Approval for VIIBRYD

March 17, 2015 8:10 am | News | Comments

Actavis announced that the FDA has approved a lower therapeutic dose of VIIBRYD (vilazodone HCl) (20mg) to accompany the 40 mg daily therapeutic dose.

EPA, FDA Sign Data Sharing Agreement

March 17, 2015 7:56 am | by Andy Szal, Digital Reporter | News | Comments

The Environmental Protection Agency and the Food and Drug Administration signed an agreement to share data relating to pesticides and toxic substances, the agencies announced Monday.

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