GW Pharmaceuticals Receives Orphan Drug Designation For Cannabidiol Treatment of Neonatal Hypoxic-Ischemic EncephalopathyApril 24, 2015 11:15 am | by Globe Newswire | News | Comments
There are currently no FDA-approved medicines specifically indicated for NHIE.
Hospira is issuing a voluntary recall of one lot of Preservative-Free Bupivacaine HCl Injection...
Capricor Therapeutics, Inc. today announced that it has been granted orphan drug designation by...
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.
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).
Stratus Pharmaceuticals marketed and distributed unapproved prescription drug products that were manufactured by Sonar Products, Inc., of Carlstadt, New Jersey.
OriGen Biomedical initiated a nationwide recall for one lot of Reinforced Dual Lumen ECMO catheters.
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.
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.
The issue also intensified criticisms of the FDA.
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.
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 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.
The FDA has granted Fast Track designation to BioBlast's Cabaletta for the treatment of patients with Oculopharyngeal Muscular Dystrophy (OPMD).
Prolong Pharmaceuticals, LLC, a biopharmaceutical company, announced that the FDA has granted Orphan Drug Designation for its Sickle Cell Disease (SCD) treatment.
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.
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.
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.
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.
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.
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 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.
The FDA has expanded the approved use for Eylea (aflibercept) injection to treat diabetic retinopathy in patients with diabetic macular edema.
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.
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 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 announced that the FDA has approved a lower therapeutic dose of VIIBRYD (vilazodone HCl) (20mg) to accompany the 40 mg daily therapeutic dose.
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