Evotaz is coformulated to be one pill, once-daily, combining the protease inhibitor atazanavir, which is marketed as Reyataz (atazanavir 200 mg/300 mg) capsules, and cobicistat, a pharmacokinetic enhancer marketed by Gilead Sciences.
Pharmacyclics has announced that the FDA has granted single-agent IMBRUVICA (ibrutinib) regular...
U.S. Food and Drug Administration Commissioner Margaret A. Hamburg, M.D., has appointed Robert...
Teva Pharmaceutical has announced the Food and Drug Administration (FDA) approval of the first...
The U.S. Food and Drug Administration is considering a proposal that would allow Oxitec to release millions of mosquitoes in an effort to fight the painful dengue and chikungunya viruses.
Symplmed Pharmaceuticals has announced that the FDA has approved Prestalia® (perindopril arginine and amlodipine) tablets, licensed from Servier (Suresnes, France), for the treatment of hypertension.
Octapharma announced that the FDA has approved the company’s manufacturing facility in Vienna, Austria for the production of Octagam 10% [Immune Globulin Intravenous (Human) 10% (100 mg/mL) Liquid Preparation], which became available in the U.S. during October 2014.
Regeneron Pharmaceuticals and Sanofi today announced that the FDA has accepted for priority review the Biologics License Application (BLA) for (alirocumab). Under the Prescription Drug User Fee Act (PDUFA), the goal for a priority review is six months, for a target action date of July 24, 2015.
Insys Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to its Liposomal Encapsulated Paclitaxel (LEP) candidate for the treatment of ovarian cancer.
Consumers and drug and device manufacturers are changing practices and shifting attitudes toward the Food and Drug Administration (FDA). Increased pressures for speedy access to breakthrough drugs and medical devices, and a focus on value in addition to medical benefit, are driving these changes.
Impax Laboratories announced today that the FDA has approved generic Lamictal (lamotrigine) Orally Disintegrating Tablets, 25mg, 50mg, 100mg and 200mg in blister packaging. Impax will promptly initiate commercialization of this product through Global Pharmaceuticals, Impax's generic division.
FDA Panel Recommends Approval of Astellas’ CRESEMBA for Treatment of Invasive Aspergillosis and MucormycosisJanuary 22, 2015 3:45 pm | News | Comments
The FDA Anti-infective Drugs Advisory Committee voted unanimously to recommend approval of the investigational once-daily intravenous and oral broad-spectrum CRESEMBA for the treatment of invasive aspergillosis, and 8 to 2 with one abstention to recommend approval for the treatment of invasive mucormycosis.
Warren's bill would require that whenever drug companies enter into a settlement with the government over alleged wrongdoing, they must pay a portion of their annual profits over five years to support research at the NIH and the FDA.
With special permission from the Food and Drug Administration and multiple drug companies, an Arizona hospital is testing medicines very early in development and never tried on brain tumors before.
Novartis announced that the FDA has approved Cosentyx (secukinumab) for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.
FDA Approves Baxter's PHOXILLUM Solution for Electrolyte Management During Continuous Renal Replacement TherapyJanuary 21, 2015 8:15 am | News | Comments
Baxter International has announced the FDA has approved PHOXILLUM Renal Replacement Solutions as replacement solutions in continuous renal replacement therapy to correct electrolyte and acid-base imbalances, and in case of drug poisoning when CRRT is used to remove dialyzable substances.
In the US, the FDA has accepted for review the New Drug Application (NDA) for brivaracetam as adjunctive therapy for the treatment of partial-onset seizures in patients from 16 years of age with epilepsy, and in the EU, the European Medicines Agency has validated for review the Marketing Authorization Application (MAA) for brivaracetam in the same proposed indication.
Janssen Research & Development has announced that the U.S. Food and Drug Administration has granted Priority Review for the New Drug Application (NDA) for three-month atypical antipsychotic paliperidone palmitate to treat schizophrenia in adults.
A California dietary supplement manufacturer was ordered by a federal court to stop selling its products until the company comes into compliance with the U.S. Food and Drug Administration’s dietary supplement manufacturing regulations and other requirements listed in the consent decree.
This is the first Fresenius Kabi drug approved by the FDA since the agency upgraded the status of the company’s pharmaceutical manufacturing facility in Grand Island, N.Y., earlier this month.
Auspex Pharmaceuticals has announced that the FDA has granted orphan drug designation to Auspex's investigational compound SD-809 for the treatment of Tourette syndrome in the pediatric population (defined as zero through 16 years of age).
The Maestro Rechargeable System uses electrodes implanted in the abdomen to stimulate the vagus nerve, which signals to the brain that the stomach is empty or full. Patients and doctors can adjust the device settings using external controllers.
Cytori Therapeutics announced today that the Center for Biologics Evaluation and Research, a division of the FDA, has given final approval to its application for an Investigational Device Exemption to begin a pivotal trial to evaluate Cytori Cell Therapy™ as a potential treatment for impaired hand function in scleroderma.
Daiichi Sankyo Company today announced that the FDA has approved SAVAYSA Tablets, an oral, once-daily selective factor Xa-inhibitor, to reduce the risk of stroke and systemic embolism (SE) in patients with non-valvular atrial fibrillation (NVAF).
A panel of Food and Drug Administration experts ruled that the Novartis' version of Neupogen is highly similar to Amgen's original blockbuster biotech drug, which is used to boost blood cells that help cancer patients fight off infections.
Impax Pharmaceuticals today announced that the FDA approved RYTARY, an extended-release oral capsule formulation of carbidopa-levodopa, for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication and/or manganese intoxication.
Soligenix announced today that its SGX301 (synthetic hypericin) development program for the first-line treatment of cutaneous T-cell lymphoma (CTCL) has received "Fast Track" designation from the FDA.
Lyophilization Services of New England, Inc. (LSNE) announced today that following an FDA Pre-Approval Inspection (PAI) in November 2014, their Harvey Road manufacturing site has received approval to manufacture commercial drug product for US distribution.
Actavis and Gedeon Richter today announced that FDA has acknowledged receipt of Actavis' New Drug Application resubmission for its atypical antipsychotic cariprazine, a potent dopamine D3/D2 receptor partial agonist with preferential binding to D3 receptors.
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