The Food and Drug Administration said Wednesday that it reached a $1.25 million settlement with a division of Johnson & Johnson over allegations that it knowingly shipped faulty sterilization equipment used by hospitals.
Immunomedics said today its cancer drug IMMU-132 will receive orphan drug incentives as a...
Arca believes it has identified genetic variations that predict whether a patient will be helped...
The co-owner of a now-defunct Virginia drug company has pleaded guilty to illegally importing...
Biogen Idec announced today that the U.S. Food and Drug Administration (FDA) has extended the initial Prescription Drug User Fee Act (PDUFA) date for its review of the Biologics License Application (BLA) for ALPROLIX™, the company’s investigational long-lasting recombinant factor IX Fc fusion protein candidate for hemophilia B.
AcelRx Pharmaceuticals, Inc. has announced that the Zalviso New Drug Application (NDA) was accepted for filing by the FDA on November 26, 2013. The acceptance for filing of the NDA indicates the FDA has determined that the application is sufficiently complete to permit a substantive review.
Specialty drugmaker BTG PLC has received U.S. approval to market an injectable drug to treat patients with varicose veins. The drug, Varithena, is pharmaceutical foam dispensed from a canister device.
Purdue Pharma L.P. announced that the FDA has accepted for review a New Drug Application (NDA) for Targiniq ER (oxycodone HCl/naloxone HCl controlled-release) Tablets CII, for the management of chronic pain. he NDA is based on the results of a 12-week, double-blind, randomized, placebo-controlled U.S. clinical trial with 600 opioid-experienced patients as well as supporting data from other clinical studies.
A government study offers a new theory on why the whooping cough vaccine doesn't seem to be working as well as expected. The research suggests that while the vaccine may keep people from getting sick, it doesn't prevent them from spreading whooping cough — also known as pertussis — to others.
The Food and Drug Administration is lifting severe safety restrictions on the former blockbuster diabetes pill Avandia, citing recent data suggesting that the much-debated medication does not increase the risk of heart attack.
The Food and Drug Administration has ordered Google-backed genetic test maker 23andMe to halt sales of its personalized DNA test kits, saying the company has failed to show that the technology is supported by science.
Orexigen Therapeutics Inc. shares jumped Monday after the drugmaker said it expects to resubmit its application for the potential weight-loss treatment Contrave to federal regulators in the next few weeks. The La Jolla, Calif., company said Monday that the Food and Drug Administration could...
Shares of troubled drugmaker Amarin fell again Friday after the Food and Drug Administration refused to reconsider a recent decision that casts doubt on the future of the company's lead product.
The FDA has expanded approval of a Bayer drug to treat patients with thyroid cancer. Bayer's pill Nexavar is already approved to treat kidney cancer and liver cancer that cannot be surgically removed. Now the FDA has approved the drug to treat cancerous growth of the thyroid gland, which is located in the neck.
The U.S. government has for the first time approved an adjuvanted vaccine to protect against H5N1 bird flu. The vaccine was made by Quebec City-based ID Biomedical, a subsidiary of pharmaceutical giant GlaxoSmithKline.
Federal regulators on Friday approved a new drug from Johnson & Johnson for use in treating chronic hepatitis C infections. The U.S. Food and Drug Administration said it approved the drug, a protease inhibitor that blocks a protein needed by the virus to replicate.
A potential rheumatoid arthritis treatment from French drugmaker Sanofi and its U.S. development partner Regeneron Pharmaceuticals Inc. fared better than a fake drug at improving disease signs and symptoms in a late-stage study.
Pfizer has announced that the FDA has granted XALKORI ® (crizotinib) regular approval for the treatment of patients with metastatic ALK-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
Forest Labs said regulators want more information on the drugmaker's potential schizophrenia treatment cariprazine before they decide whether to approve the drug. The potential drug aims to treat bipolar I disorder, which is also known as manic-depressive illness and characterized by unusual shifts in a person's mood, energy level or ability to carry out daily tasks.
BioMarin Pharmaceutical Inc. said Tuesday that a U.S. Food and Drug Administration advisory committee has voted in favor of its drug Vimizim for the treatment of Morquio A syndrome. Vimizim is designed to treat a rare disease called mucopolysaccharidosis Type IVA, or Morquio A Syndrome.
Merck said Monday that U.S. regulators will make a faster decision on an IV formulation of its antifungal drug Noxafil. Merck said the IV version of the drug will get a priority review. That means the Food and Drug Administration will make a decision in six months instead of the usual 10 months.
Federal health officials say that defects in some Medtronic devices used in heart procedures are severe enough that they could cause serious injury or death. The warning covers about 15,000 recalled guidewires, which are inserted through an artery and used to guide other devices into place, such as stents to hold open blocked arteries.
Princeton University officials are deciding whether to give students a meningitis vaccine that hasn't been approved in the U.S. to stop the spread of the disease. A decision could be made as early as today.
Valeant Pharmaceuticals said Friday that the Food and Drug Administration approved its Luzu cream, which is designed to treat fungal infections. The Canadian drugmaker said Luzu, or luliconazole, is intended to treat athlete's foot, jock itch, and ringworm. It said the cream is indicated for...
GW Pharmaceuticals announced today that the U.S. Food and Drug Administration has granted orphan drug designation for Epidiolex, which contains plant-derived Cannabidiol (CBD) as its active ingredient, for use in treating children with Dravet syndrome, a rare and severe form of infantile-onset, genetic, drug-resistant epilepsy syndrome.
The medical profession has issued new guidelines for fighting the nation's obesity epidemic, and they urge physicians to be a lot more aggressive about helping patients drop those extra pounds. Doctors should calculate your body mass index, a weight-to-height ratio. And if you need to lose weight, they should come up with a plan and send you for counseling.
The FDA has approved Imbruvica (ibrutinib) to treat patients with mantle cell lymphoma (MCL), a rare and aggressive type of blood cancer. MCL is a rare form of non-Hodgkin lymphoma and represents about 6 percent of all non-Hodgkin lymphoma cases in the United States. By the time MCL is diagnosed, it usually has already spread to the lymph nodes, bone marrow and other organs.
Shares of Vanda Pharmaceuticals nearly doubled in value Tuesday as a group of Food and Drug Administration advisors' prepared to review the company's sleep disorder drug tasimelteon.
They are among our most personal daily decisions: what to eat or drink. Maybe what to inhale. Now that the government's banning trans fat, does that mean it's revving up to take away our choice to consume all sorts of other unhealthy stuff?
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