US Food and Drug Administration (FDA) has approved Pfizer's Bosulf (bosutinib) to treat adult patients with chronic, accelerated or blast phase Philadelphia chromosome-positive (Ph+) (CML) with resistance to prior therapy. Bosulif is a ...
Tags: bosulf, bosutinib, kinase inhibitor, Philadelphia chromosome-positive
Inhaled nitric oxide drug products developer GeNO has received four additional US patents on its proprietary inhaled nitric oxide (NO) generation chemistry and delivery technology, bringing the total number of US patents to sixteen. The ...
Tags: inhaled nitric oxide drug, NO, NO2, GeNO
Genzyme, a Sanofi company, has submitted a new drug application to the FDA seeking approval for KYNAMRO for the treatment of patients with homozygous familial hypercholesterolemia (HoFH). The submission is based on trial in which ...
Tags: KYNAMRO, homozygous familial hypercholesterolemia, HoFH
Genzyme, a Sanofi company, has submitted a supplemental biologics license application (sBLA) to the FDA and marketing authorization application (MAA) to EMA for Lemtrada to treat relapsing multiple sclerosis (RMS). In collaboration with ...
Tags: sBLA, relapsing multiple sclerosis, RMS
The FDA has accepted the review of Zogenix new drug application (NDA) for Zohydro ER (hydrocodone bitartrate extended-release capsules) for the treatment of moderate to severe chronic pain. Zohydro ER is an oral, single-entity (without ...
Tags: Zohydro ER, hydrocodone bitartrate extended-release capsules
Bayer HealthCare has filed a new drug application (NDA) with the FDA seeking approval for the oral multi-kinase inhibitor regorafenib to treat patients with metastatic colorectal cancer (mCRC). The company has even filed an application ...
Tags: oral multi-kinase inhibitor regorafenib, metastatic colorectal cancer
FDA has designated Stratatech's universal human skin substitute, StrataGraft, as an orphan drug for the treatment of partial and full thickness skin burns. As per the orphan drug status, the company will be able to market StrataGraft once ...
The US Food and Drug Administration (FDA) has granted accelerated approval to Talon Therapeutics' Marqibo (vinCRIStine sulfate LIPOSOME injection). Marqibo, a sphingomyelin/cholesterol liposome-encapsulated formulation of vincristine ...
The US Food and Drug Administration (FDA) has announced that manufacturers have voluntarily withdrawn greaseproofing agents known as C8 compounds from the marketplace. These compounds are used as coatings on paper wrappers and containers ...
Tags: compounds, coatings on paper wrappers and containers, contact with food
Mylan Pharmaceuticals has gained final FDA approval for its abbreviated new drug application (ANDA) for Fluvastatin Capsules USP, 20mg and 40mg, and began shipment of the product. The product, a generic version of Novartis' Lescol ...
Mylan Pharmaceuticals has won final FDA approval for its abbreviated new drug application (ANDA) of Itraconazole capsules, 100mg, the generic version of Janssen Pharmaceutical's Sporanox capsules. The generic Sporanox is indicated for the ...
Gilead Sciences Truvada (emtricitabine and tenofovir disoproxil fumarate) has received approval from the US Food and Drug Administration (FDA). Truvada is the first agent to get approval for HIV prevention in uninfected adults, a strategy ...
Tags: HIV testing, Truvada, PrEP, pre-exposure prophylaxis
The US Food and Drug Administration (FDA) has cleared Sigma-Tau Pharmaceuticals' topical ophthalmic therapeutic to treat corneal cystine crystals in cystinosis patients. The CYSTARAN 0.44% solution, which is developed in collaboration ...
Mylan Pharmaceuticals has filed suit against FDA seeking to overturn a decision that gives Teva Pharmaceuticals 180-day exclusivity to market the generic version of its affiliate Cephalon's Provigil. Mylan alleges Teva did not keep up ...
Two Moms in the Raw,a firm based Lafayette,Colorado,is voluntarily recalling a limited number of 4 oz packages of Pesto Sea Crackers as they may contain undeclared peanuts,according to the US Food and Drug Administration(FDA). FDA noted ...
Tags: FDA, Pesto Sea Crackers, peanuts, allergies