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...
The FDA has expanded the approved use for Eylea (aflibercept) injection to treat diabetic...
Vertex Pharmaceuticals has announced that the FDA approved KALYDECO® for use in children ages 2...
Actavis announced that the FDA has approved a lower therapeutic dose of VIIBRYD (vilazodone HCl) (20mg) to accompany the 40 mg daily therapeutic dose.
Actavis announced that the FDA has approved its supplemental new drug application (sNDA) for SAPHRIS (asenapine) as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder in pediatric patients (ages 10 - 17).
A powdered alcohol intended to be mixed up into drinks has gained approval from a federal regulator. The product, called Palcohol, had received the greenlight from the Alcohol and Tobacco Tax and Trade Bureau briefly last year before the bureau backtracked and said the label approvals had been given in error.
Government health officials on Friday approved the first lower-cost copy of a biotech drug in the U.S., a long-awaited milestone that could save billions for insurers, doctors and patients.
FDA Approves Opdivo for the Treatment of Patients with Previously Treated Metastatic Squamous Non-Small Cell Lung CancerMarch 4, 2015 11:04 pm | News | Comments
Bristol-Myers Squibb Company has announced that the U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) injection, for intravenous use, for the treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.
Pfizer has announced that the European Commission approved an expanded indication for the use of Prevenar 13 for the prevention of pneumonia caused by the 13 pneumococcal serotypes in the vaccine in adults aged 18 years and older.
Federal health officials have approved a new antibiotic combination to treat several hard-to-treat infections. The drug contains two ingredients, cephalosporin and avibactam, designed to help fight antibiotic-resistant bacteria.
The U.S. Food and Drug Administration has approved Farydak (panobinostat) for the treatment of patients with multiple myeloma. Multiple myeloma is a form of blood cancer that arises from plasma cells, a type of white blood cell, found in bone marrow.
Eisai has announced that the FDA approved the company's receptor tyrosine kinase inhibitor LENVIMA (lenvatinib) for the treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (RAI-R DTC).
The FDA has cleared the Cepheid Xpert MTB/RIF Assay to help physicians determine if patients with suspected tuberculosis (TB) can be removed from airborne infection isolation.
FDA Approves Genentech’s Lucentis® for Treatment of Diabetic Retinopathy in People With Diabetic Macular EdemaFebruary 9, 2015 7:12 am | News | Comments
Genentech, a member of the Roche Group announced that the FDA approved Lucentis® for the treatment of diabetic retinopathy (DR) in people with diabetic macular edema (DME). DME impacts nearly 750,000 Americans, about 10 percent of people with DR.
Closer and more frequent communications with the FDA are likely the main factors leading to a shorter approval time for breakthrough drug therapies, according to Fitch Ratings. Breakthrough therapy approvals more than tripled in 2014 versus 2013.
The FDA has expanded the approved uses of Vyvanse (lisdexamfetamine dimesylate) to treat binge-eating disorder in adults. The drug is the first FDA-approved medication to treat this condition.
Zogenix has received U.S. approval for a new formulation of its much-debated painkiller Zohydro that is intended to be harder to abuse, though the company is still working on studies needed to promote that claim.
The FDA has approved Glyxambi (empagliflozin/linagliptin) tablets, from Boehringer Ingelheim Pharmaceuticals and Eli Lilly as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes (T2D) when both empagliflozin and linagliptin are appropriate treatments.
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 (full) approval in all lines of therapy as the first and only treatment for patients with Waldenstrom's macroglobulinemia (WM), a rare, indolent type of B-cell lymphoma.
Teva Pharmaceutical has announced the Food and Drug Administration (FDA) approval of the first generic equivalent to Nexium (esomeprazole magnesium) Delayed-Release Capsules in the United States.
Merck announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending approval of the investigational antibiotic SIVEXTRO® for the treatment of acute bacterial skin and skin structure infections in adults.
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.
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 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.
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.
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.
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