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...
The Food and Drug Administration on Tuesday approved the first pill-based drug for women who...
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.
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.
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...
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.
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.
The U.S. Food and Drug Administration today approved Kcentra (Prothrombin Complex Concentrate, Human) for the urgent reversal of vitamin K antagonist (VKA) anticoagulation in adults with acute major bleeding. Plasma is the only other product approved for this use in the United States.
The Food and Drug Administration recently cleared ResMed's home variable positive airway pressure (VPAP) device — also known as bilevel PAP — for the treatment of respiratory disorders such as COPD, giving severe COPD sufferers a weapon in the fight to stay out of the hospital.
Merck announced the FDA has designated lambrolizumab as a Breakthrough Therapy for the treatment of patients with advanced melanoma. Lambrolizumab is Merck's investigational antibody therapy targeting Programmed Death receptor (PD-1) that is currently being evaluated for the treatment of patients with advanced melanoma, and other tumor types.
PERJETA (pertuzumab), in combination with the current standard of care, HERCEPTIN® (trastuzumab) and docetaxel chemotherapy, is approved for the treatment of patients with HER2-positive metastatic breast cancer (mBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
Sucampo Pharmaceuticals Inc. and Takeda Pharmaceuticals said Tuesday that they received U.S. regulatory to market their constipation treatment Amitiza for a new use. The Food and Drug Administration approved the pill for constipation caused by opioid pain medications used by patients with...
Teva Pharmaceutical Industries Ltd. and Xenon Pharmaceuticals Inc. announced today that the FDA has granted orphan-drug designation to the investigational drug XEN402 being developed for the treatment of pain associated with erythromelalgia.
BD Rx Inc. announced that the FDA has approved the second drug to be offered in the recently launched BD SimplistT line of ready-to-administer prefilled generic injectables. The second BD Simplist product to launch is Metoclopramide Injection, USP, an injectable antiemetic.
Neuralstem, Inc. announced that it has received approval from the Food and Drug Administration (FDA) to begin dosing the third and final cohort of patients in its ongoing Phase Ib to test the safety of NSI-189 in the treatment of major depressive disorder (MDD).
Amarin Corporation plc, a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today the approval of the Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) to add Chemport, Inc. as an additional Vascepa(R) (icosapent ethyl) active pharmaceutical ingredient (API) supplier.
VIVUS Announces FDA Approval of Qsymia REMS Modification Allowing Access Through Certified Retail PharmaciesApril 17, 2013 8:24 am | News | Comments
VIVUS has announced that the FDA has approved its amendment and modification to the Risk Evaluation and Mitigation Strategy (REMS) for Qsymia capsules CIV. The amendment, submitted in October 2012, allows Qsymiato be dispensed through certified retail pharmacies, in addition to the existing network of certified mail-order pharmacies.
The FDA has approved updated labeling for Purdue Pharma L.P.’s reformulated OxyContin (oxycodone hydrochloride controlled-release) tablets. The new labeling indicates that the product has physical and chemical properties that are expected to make abuse via injection difficult and to reduce abuse via the intranasal route (snorting).
Taro Pharmaceutical Industries Ltd. said Friday the Food and Drug Administration approved its Topicort spray as a treatment for plaque psoriasis. The company said Topicort, or desoximetasone, is approved for patients age 18 and older. Taro said U.S. consumers spend about $100 million per year on...
The Maryland General Assembly on Monday approved a measure allowing medical marijuana programs at research centers that choose to participate. The state Senate approved the measure, 42-4. Ten of the Senate's 12 Republicans joined 32 Democrats, while two Democrats and two Republicans voted against it.
A treatment pulled off the market 30 years ago has won Food and Drug Administration approval again as the only drug specifically designated to treat morning sickness. That long-ago safety scare, prompted by hundreds of lawsuits claiming birth defects, proved to be a false alarm.
Genzyme, a Sanofi company, announced today Argentina’s National Administration of Drugs, Food and Medical Technology (ANMAT) has approved once-daily, oral AUBAGIO® 14 mg as a new treatment indicated for patients with relapsing forms of multiple sclerosis (MS).
Tris Pharma, a specialty pharmaceutical company focused on developing innovative drug delivery technologies, today announced that the FDA has approved its New Drug Application (NDA) for Karbinal ER (carbinoxamine maleate) Extended-release Oral Suspension 4mg/5ml, the first sustained-release histamine receptor blocking agent indicated for the treatment of seasonal and perennial allergic rhinitis in children ages 2 and up.