The U.S. Food and Drug Administration said Wednesday it approved a new drug from Biogen Idec to control multiple sclerosis in adults with hard-to-treat forms of the disease.The twice-a-day capsules, called Tecfidera, offer a new option for multiple sclerosis, a debilitating disease in which the body attacks its own nervous system.
The U.S. Food and Drug Administration said Wednesday it approved a new drug from Biogen Idec to...
Clinical Specialties is voluntarily recalling All Lots of All Sterile products repackaged and...
Medprep Consulting Recalls All Lots of Magnesium Sulfate 2gm In Dextrose 5% In Water, 50ml For InjectionMarch 18, 2013 8:04 am | News | Comments
The level of recall is to the user, that is, regional hospital pharmacies and related...
Federal health regulators say an experimental insomnia drug from Merck can help patients fall asleep, but it also carries worrisome side effects, including daytime drowsiness and suicidal thinking. The Food and Drug Administration on Monday released its review of the company's sleep aid,...
CD-3 is a new tool in the Food and Drug Administration’s fight against counterfeit products. CD-3 is a low-cost, portable tool that uses light to detect counterfeit products. CD-3 can be deployed anywhere and is helping the FDA protect consumers.
Changes in the marketplace have forced the public health community to wrestle with the idea that some tobacco products may pose less of a health risk than others, the new head of the Food and Drug Administration's tobacco control efforts told an industry group on Thursday.
Oramed Pharmaceuticals Inc. a developer of oral drug delivery systems, announced today that the United States Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug application(IND) for ORMD-0801, its oral insulin capsule.
The U.S. Food and Drug Administration has approved a new injectable drug that uses radiation to treat advanced prostate cancer that has spread to the bones. The FDA said Wednesday it approved the drug, Xofigo from Bayer Pharmaceuticals, for men whose cancer has grown into bone tumors even after receiving medication or surgery to lower testosterone.
Janssen Biotech, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved SIMPONI (golimumab) for the treatment of moderately to severely active ulcerative colitis (UC) in adult patients who have demonstrated corticosteroid dependence or who have had an inadequate response to or failed to tolerate oral aminosalicylates, oral corticosteroids, azathioprine, or 6-mercaptopurine.
Those who take products containing zolpidem, best know by the drug’s brand name Ambien, are now being advised by the Food and Drug Administration to take less of the medication. Patients who take the drug, especially the extended release version, are advised not to drive the next day as levels of the drug remain high in the body
A surprising new report questions public health efforts to get Americans to sharply cut back on salt, saying it's not clear whether eating super-low levels is worth the struggle. Make no mistake: Most Americans eat way too much salt, not just from salt shakers but because of sodium hidden inside processed foods and restaurant meals.
Seattle Genetics, Inc. announced that the FDA has accepted for filing a supplement to the Biologics License Application supporting the use of ADCETRIS for retreatment and extended duration beyond 16 cycles of therapy in relapsed Hodgkin lymphoma and systemic anaplastic large cell lymphoma.
Biogen Idec announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) for the marketing approval of ELOCTATE™ (recombinant factor VIII Fc fusion protein) for the treatment of hemophilia A.
In a surprise move Friday, federal health regulators denied a request by Endo Health Solutions to block generic versions of its painkiller Opana ER, which the company argued are more easily abused than its branded product. Endo's Opana ER is a long-acting narcotic drug used to treat moderate and...
State pharmacy officials on Thursday threw their support behind a proposal giving the Food and Drug Administration authority over large compounding pharmacies, in an effort to head off more outbreaks tied to contaminated medications. The head of the National Association of Boards of Pharmacy told Senate lawmakers that his group welcomes FDA action against pharmacies like the one that triggered a deadly meningitis outbreak last year.
WHITEHOUSE STATION, N.J. (AP) — Drugmaker Merck & Co. says the Food and Drug Administration is reviewing its second application to sell a new type of allergy treatment meant to gradually reduce allergic reactions over time, rather than just relieving sneezing, itching and other symptoms...
Ariad Pharmaceuticals Inc. said Tuesday that revenue from its leukemia pill Iclusig, its first approved drug, totaled $6.4 million in the first quarter, surpassing Wall Street's expectations. The Food and Drug Administration approved Iclusig in December as a treatment for two types of the disease.
Cubist Pharmaceuticals Inc. said Tuesday that the Food and Drug Administration has given fast-track status to an experimental antibiotic regimen as a treatment for three types of infections. The company is studying a combination of ceftolozane and tazobactam as a treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia as well as complicated urinary-tract infections.
Indoor tanning beds would come with new warnings about the risk of cancer and be subject to more stringent federal oversight under a proposal unveiled Monday by the Food and Drug Administration. The FDA has regulated tanning beds and sun lamps for over 30 years, but for the first time ever the agency says those devices should not be used by people under age 18.
U.S. health regulators are warning doctors and women of child-bearing age that half-a-dozen medications used to treat migraine headaches can decrease children's intelligence if taken while their mothers are pregnant. The Food and Drug Administration said Monday that the drugs, including Depakote and Depacon, should never be taken by pregnant women for the prevention of migraine headaches.
WHITEHOUSE STATION, N.J. (AP) — Merck & Co. said Friday that it received U.S. marketing approval for the new combination cholesterol drug Liptruzet, which combines the company's drug Zetia with a generic version of the mega-blockbuster drug Lipitor. The Food and Drug Administration approved...
Bristol-Myers Squibb Co. said Friday that U.S. regulators expanded approval of its HIV drug Sustiva to children as young as three months old. The capsule-based drug was first approved in 1998 to treat HIV-infected children who are age three and older and weigh at least 22 pounds. The new approval...
The FDA is reviewing whether triclosan, an antibacterial contained in liquid soap and body wash may be ineffective or even harmful to humans. Recent studies on animals have shown an increased risk of infertility, early puberty and other hormonal issues.
FDA Approves Bristol-Myers Squibb’s sNDA for Use of SUSTIVA® (efavirenz) in HIV-1 Infected Pediatric PatientsMay 3, 2013 8:32 am | News | Comments
Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for SUSTIVA ® (efavirenz), including dosing recommendations for HIV-1 infected pediatric patients three months to three years old and weighing at least 3.5 kg.
Hyperion Therapeutics Inc. said Thursday that its drug Ravicti received orphan drug status, giving the drug seven years of marketing exclusivity. Ravicti was approved Feb. 1 as a treatment for urea cycle disorders, a rare type of enzyme deficiency, in patients 2 years and older. The Food and Drug Administration's decision to grant orphan drug status will keep similar products off the market until Feb. 1, 2020.
It's a chemical that's been in U.S. households for more than 40 years, from the body wash in your bathroom shower to the knives on your kitchen counter to the bedding in your baby's basinet. But federal health regulators are just now deciding whether triclosan — the germ-killing ingredient found in an estimated 75 percent of antibacterial liquid soaps and body washes sold in the U.S. — is ineffective, or worse, harmful.
Alimera Sciences, Inc. announced that its recent resubmission of the New Drug Application for ILUVIEN@ has been acknowledged as received by the FDA as a complete class 2 response to the FDA's November 2011 letter and that a new Prescription Drug User Fee Act goal date of October 17, 2013 has been established.
The FDA announced on Tuesday that it lowered to 15 the age at which women can buy Teva’s Plan B One-Step (levonorgestrel) emergency oral contraceptive and also allowed the drug to be available over-the-counter without a prescription. Previously, only those aged 17 or older could obtain the emergency oral contraceptive without a prescription.