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European Commission Approves Lynparza™ for Advanced BRCA-Mutated Ovarian cancer

December 18, 2014 9:04 am | News | Comments

AstraZeneca today announced that the European Commission has granted Marketing Authorization for Lynparza™ capsules as the first therapy for the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cance.

Alcon's Xtoro Approved to Treat Swimmer’s Ear

December 17, 2014 4:17 pm | News | Comments

The FDA has approved Xtoro (finafloxacin otic suspension), a new drug used to treat acute otitis...

FDA Approves Pathogen Reduction System to Treat Plasma

December 17, 2014 10:24 am | News | Comments

The FDA has approved the Intercept Blood System for plasma, the first pathogen reduction system...

FDA Approves Ipsen's Somatuline® Depot® Injection for the Treatment of Gastroenteropancreatic Neuroendocrine Tumors

December 17, 2014 8:23 am | News | Comments

Ipsen Biopharmaceuticals announced that Somatuline® Depot® Injection 120 mg (referred to as...

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FDA Approves Novartis’ Signifor for Acromegaly

December 16, 2014 8:12 am | News | Comments

Acromegaly is a rare, debilitating endocrine disorder caused by the excess production of growth hormone (GH) and insulin-like growth factor-1 (IGF-1). In the majority of cases, the disease is caused by a non-cancerous tumor on the pituitary gland.

FDA Approves Sanofi Pasteur’s Fluzone Vaccine

December 15, 2014 8:30 am | News | Comments

Sanofi Pasteur, the vaccines division of Sanofi, has announced that the FDA has approved the supplemental biologics license application for Fluzone Intradermal Quadrivalent vaccine. Fluzone Intradermal vaccine, which has been available in trivalent formulation for three years, is now available in a quadrivalent formulation to help protect against four strains of influenza virus.

Lilly's Cyramza Gets New Marketing Approval

December 15, 2014 8:12 am | News | Comments

The Food and Drug Administration is allowing Lilly to market the drug as a treatment for cases that have spread. Earlier this year the FDA approved the drug as a treatment for gastric cancer.          

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FDA Approves Test to Confirm Presence of Human T-cell Lymphotropic Virus-I/II Antibodies

December 11, 2014 1:53 pm | News | Comments

The FDA has approved MP Diagnostics HTLV Blot 2.4, the first FDA-licensed supplemental test for Human T-cell Lymphotropic Virus-I/II (HTLV-I/II). This test is intended for use as an additional, more specific test for human serum or plasma specimens that have previously tested positive on an FDA-licensed HTLV-I/II blood donor screening test.

FDA OKs Gardasil 9 to Prevent Cancers Caused by Five Additional Types of HPV

December 10, 2014 3:27 pm | News | Comments

The FDA has approved Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) for the prevention of certain diseases caused by nine types of Human Papillomavirus (HPV). Covering nine HPV types, five more HPV types than Gardasil, Gardasil 9 has the potential to prevent approximately 90 percent of cervical, vulvar, vaginal and anal cancers.

FDA Approves Amgen's XGEVA

December 8, 2014 10:40 am | News | Comments

Amgen announced that the FDA has approved a new indication for XGEVA (denosumab) for the treatment of hypercalcemia of malignancy (HCM) refractory to bisphosphonate therapy. XGEVA was approved and granted Orphan Drug Designation by the FDA.  

FDA Approves Labeling Update of Abilify Maintena®

December 8, 2014 8:30 am | News | Comments

Otsuka Pharmaceutical and H. Lundbeck A/S announced that FDA approved the labeling update of Abilify Maintena® for extended-release injectable suspension. The approval was based on results from a controlled clinical study of acutely relapsed adults with schizophrenia.

FDA Approves Jakafi for Patients with Uncontrolled Polycythemia Vera

December 4, 2014 11:21 am | News | Comments

Incyte Corporation announced that the FDA has approved Jakafi® for the treatment of patients with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea. Jakafi, an oral medication, is the first and only product approved by the FDA for PV, a rare and progressive blood cancer.

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FDA Approves Blincyto for Rare Form of Acute Lymphoblastic Leukemia

December 3, 2014 3:09 pm | News | Comments

The U.S. Food and Drug Administration has approved Blincyto (blinatumomab) to treat patients with Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL), an uncommon form of ALL.      

FDA Approves Priftin Tablets for the Treatment of Latent Tuberculosis Infection

December 2, 2014 9:08 am | News | Comments

Sanofi announced today that following a priority review, the FDA has approved Priftin in combination with isoniazid for a new indication for the treatment of latent tuberculosis infection in patients two years of age and older at high risk of progression to tuberculosis disease.

FDA Approves Valeant’s ONEXTON Acne Gel

November 25, 2014 8:13 am | News | Comments

Valeant Pharmaceuticals has received approval from the FDA for ONEXTON Gel (clindamycin phosphate and benzoyl peroxide), 1.2%/3.75%, for the once-daily treatment of comedonal (non-inflammatory) and inflammatory acne in patients 12 and older.  

FDA Approves Hard-to-Abuse Hydrocodone Pill

November 20, 2014 3:27 pm | by MATTHEW PERRONE, AP Health Writer | News | Comments

Federal health regulators have approved the first hard-to-abuse version of the painkiller hydrocodone, offering an alternative to a similar medication that has been widely criticized for lacking such safeguards.       

Lemtrada Approved for Multiple Sclerosis

November 17, 2014 8:18 am | News | Comments

The U.S. Food and Drug Administration has approved Lemtrada, a treatment for relapsing multiple sclerosis made by the drugmaker Genzyme. The drug has already been approved by the European Medicines Agency for use in the European Union and in Canada and Australia.

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FDA Approves Janssen’s Schizoaffective Disorder Treatment

November 13, 2014 1:53 pm | News | Comments

Janssen Pharmaceuticals has announced that the FDA approved the supplemental New Drug Applications (sNDAs) for the once-monthly atypical long-acting antipsychotic INVEGA SUSTENNA (paliperidone palmitate) to treat schizoaffective disorder as either monotherapy or adjunctive therapy.

FDA Approves Par Pharmaceutical’s Vasostrict Injection

November 12, 2014 8:08 am | News | Comments

Par Pharmaceutical Companieshas received approval for its New Drug Application (NDA) for Vasostrict (vasopressin injection, USP) 20 units/mL from the U.S. Food and Drug Administration (FDA) pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act.

FDA Approves Ipsen's New Delivery Device for Somatuline® Depot® (lanreotide) Injection

November 6, 2014 11:44 am | News | Comments

Ipsen Biopharmaceuticals announced that the FDA has approved a new device to deliver Somatuline® Depot® (lanreotide). The device has an enhanced, prefilled, low-volume syringe that supports full-dose delivery with no reconstitution requirements.

FDA Approves Ranbaxy’s Fenofibrate Capsules

November 6, 2014 8:43 am | News | Comments

Ranbaxy Labs has received approval from the FDA to manufacture and market Fenofibrate Capsules USP, 43 mg and 130 mg. The FDA has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Antara Capsules, 43 and 130 mg, respectively.

FDA Approves Once-Daily XIGDUO™ XR Tablets for Adults with Type 2 Diabetes

October 30, 2014 8:04 am | News | Comments

AstraZeneca today announced that the FDA has approved once-daily XIGDUO™ XR (dapagliflozin and metformin hydrochloride extended-release) for the treatment of adults with type 2 diabetes.               

FDA Grants Accelerated Approval to Pfizer’s TRUMENBA®

October 29, 2014 3:22 pm | News | Comments

Pfizer announced that the FDA has granted accelerated approval of TRUMENBA ® (meningococcal group B vaccine) for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.

Halozyme Receives FDA Approval for Additional Manufacturing Facilities For Hylenex Recombinant

October 20, 2014 9:02 am | News | Comments

The FDA approved the use of the Cook Pharmica manufacturing facility in Bloomington, Indiana for the production of bulk rHuPH20, the active ingredient used in Hylenex, and the Patheon facility in Greenville, North Carolina, for production of finished Hylenex product.

FDA Approves Esbriet to Treat Idiopathic Pulmonary Fibrosis

October 16, 2014 8:41 am | News | Comments

Idiopathic pulmonary fibrosis is a condition in which the lungs become progressively scarred over time. As a result, patients with IPF experience shortness of breath, cough, and have difficulty participating in everyday physical activities.  

FDA Approves VELCADE® for Injection for Previously Untreated Patients with Mantle Cell Lymphoma

October 9, 2014 1:48 pm | News | Comments

Millennium: The Takeda Oncology Company with its parent company, Takeda Pharmaceutical Company Limited, today announced that the FDA has approved VELCADE® for injection for use in previously untreated patients with mantle cell lymphoma. VELCADE is the first treatment in the United States to be approved for use in previously untreated patients with MCL.

FDA Approves AbbVie's HUMIRA for Patients Ages Two and Older

October 6, 2014 8:20 am | News | Comments

AbbVie has announced that the FDA has approved the extension of the HUMIRA indication for moderately to severely active polyarticular juvenile idiopathic arthritis to reducing signs and symptoms in patients ages 2 and older. HUMIRA was approved in the United States in 2008 for polyarticular juvenile idiopathic arthritis in patients ages 4 and older.

FDA Approves Revised Indication for Allergan's OZURDEX®

September 29, 2014 10:06 am | News | Comments

Allergan announced today that the U.S. Food and Drug Administration (FDA) has approved OZURDEX® (dexamethasone intravitreal implant) 0.7 mg, a sustained-release biodegradable steroid implant, for the treatment of diabetic macular edema (DME).  

Alimera, pSivida say FDA Clears Eye Implant

September 26, 2014 5:45 pm | by The Associated Press | News | Comments

Alimera Sciences and pSivida said Friday the FDA approved their eye disease implant Iluvien. Iluvien is an implant delivered by injection that is intended to treat diabetic macular edema, a condition that can cause blurred vision and blindness. 

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