The US Food and Drug Administration (FDA) has granted fast track designation for Idenix Pharmaceuticals' IDX719 to treat chronic hepatitis C infection (HCV). IDX719 is an NS5A inhibitor that demonstrated pan-genotypic activity in a recent ...
Tags: IDX719, HCV, chronic hepatitis C infection
The US Food and Drug Administration (FDA) has granted fast track designation to Alvine Pharmaceuticals' ALV003 for the potential treatment of celiac disease. Alvine is at present conducting Phase 2 trials with ALV003, an orally ...
Tags: ALV003, treatment of celiac disease, orally administered mixture
Biopharmaceutical company Zalicus has received the US FDA approval for its supplemental new drug application (sNDA) for the 32 mg dose strength of Exalgo(hydromorphone HCl) Extended-Release Tablets (CII). Exalgo is used to treat moderate ...
Tags: Exalgo Extended-Release Tablets, around-the-clock opioid analgesia
Aerial BioPharma, a biopharmaceutical company, has won FDA orphan drug designation for its narcolepsy drug in development. The issuance of designation from the FDA follows the completion of a Phase IIa study in which N05 demonstrated ...
GlaxoSmithKline (GSK) has received FDA approval for Votrient (pazopanib) for the treatment of patients with advanced soft tissue sarcoma (STS) who have received prior chemotherapy. The approval is based on the results of the randomized, ...
Tags: advanced soft tissue sarcoma, STS, soft tissue sarcomas, GlaxoSmithKline
Vivus has received approval from the US Food and Drug Administration (FDA) for its Qsymia as an adjunct to a reduced-calorie diet. Qsymia will be used to manage chronic weight in adult patients with an initial body mass index (BMI) of 30 ...
Arena Pharmaceuticals and Eisai have announced FDA approval of Belviq (lorcaserin HCl) for chronic weight management in adults who are overweight with comorbidity or obese. The FDA approved Belviq as an adjunct to a reduced-calorie diet ...
Tags: Belviq, lorcaserin HCl, chronic weight management, Arena Pharmaceuticals
Takeda Pharmaceutical Company and NPS Pharmaceuticals have announced positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for Teduglutide (Revestive) for patients with short bowel syndrome (SBS). Teduglutide, ...
Tags: short bowel syndrome, teduglutide, glucagon-like peptide 2
The FDA has approved Genzyme, a Sanofi company, Aubagio (teriflunomide) as a new once-daily, oral treatment indicated for relapsing forms of multiple sclerosis (MS). Aubagio, an immunomodulator with anti-inflammatory properties, has shown ...
Tags: Aubagio, teriflunomide, new once-daily, oral treatment
US based Watson Pharmaceuticals has filed a legal case against US Food and Drug Administration's (FDA) decision regarding the company's exclusivity for its generic version of Actos (Pioglitazone Hydrochloride 15mg, 30mg and 45mg tablets). ...
Tags: Watson Pharmaceuticals, Actos, Pioglitazone Hydrochloride
Watson Laboratories, a subsidiary of Watson Pharmaceuticals, has won FDA abbreviated new drug application approval for Diclofenac Sodium and Misoprostol Delayed-Release Tablets. The company plans to launch Diclofenac Sodium and ...
Tags: Watson Laboratories
Ironwood Pharmaceuticals, Bionomics' licensee, has submitted an investigational new drug (IND) application to the FDA to begin IW-2143 clinical trial. The trial will further evaluate pharmacokinetic profile of the anti-anxiety drug ...
Janssen Research & Development has submitted supplemental New Drug Applications (sNDAs) to the US Food and Drug Administration (FDA) for the use of Xarelto (rivaroxaban), an oral anticoagulant. Janssen said the drug is used to treat ...
Tags: Xarelto, rivaroxaban, DVT, pulmonary embolism, VTE
Perrigo Company, a healthcare company, has won final FDA approval for its abbreviated new drug application for morphine sulfate 100ml/5% oral solution. Perrigo will immediately begin the shipment of Morphine sulfate oral solution, a ...
Tags: Perrigo Company, morphine sulfate, morphine sulfate oral solution
Gilead Sciences has received US Food and Drug Administration (FDA) approval for Stribild (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg). Stribild is a complete once-daily single tablet ...