DARA BioSciences has launched a liquid version of tamoxifen under the brand name Soltamox in the US. Tamoxifen Citrate is the most common drug prescribed to treat breast cancer. Soltamox is expected to offer treatment option for ...
Tags: DARA BioSciences, tamoxifen, Soltamox, Tamoxifen Citrate
US-based Cornerstone Therapeutics has entered into an agreement to acquire the US marketing rights to Chiesi Farmaceutici's BETHKIS (Tobramycin Inhalation Solution), designed for the treatment of cystic fibrosis patients with Pseudomonas ...
Tags: US-based Cornerstone Therapeutics, Chiesi Farmaceutici's BETHKIS
The US FDA has accepted ThromboGenics'biologics license application for ocriplasmin intravitreal injection,2.5mg/ml and granted it priority review. The company proposed the injection for the treatment of symptomatic Vitreomacular ...
EffRx Pharmaceuticals has launched a new effervescent buffered oral solution (70mg), designed for the treatment of osteoporosis, in the US. The new solution, BINOSTO (alendronate sodium), is intended for the treatment of osteoporosis in ...
The United States Patent and Trademark Office(USPTO)has extended the Spectrum Pharmaceuticals US patent covering Folotyn(pralatrexate injection)for five years. The extension,which was granted through the Hatch-Waxman Act,postpones the ...
Tags: USPTO, Spectrum Folotyn Patent, pralatrexate injection
The US Food and Drug Administration(FDA)approved Actelion Pharmaceuticals'supplemental new drug application(sNDA)for second generation Veletri(epoprostenol)for injection. Veletri(epoprostenol)for injection is indicated for the treatment ...
Tags: FDA, Actelion sNDA, Actelion Pharmaceuticals, Veletri
Specialty pharmaceutical company Intelliject has received the US Food and Drug Administration(FDA)approval for its Auvi-Q(epinephrine injection,USP)used in the emergency treatment of life-threatening allergic reactions in people who are at ...
Tags: Specialty pharmaceutical company, Auvi-Q, Spencer Williamson, FDA
Regeneron Pharmaceuticals has received Japanese Ministry of Health,Labour and Welfare(MHLW)approval for its Eylea(aflibercept)injection to treat patients with neovascular age-related macular degeneration(wet AMD)symptoms. Regeneron chief ...
Tags: Regeneron Pharmaceuticals, Eylea Injection, wet AMD, George Yancopoulos
The FDA has approved Stiefel's new drug application (NDA) for Fabior (tazarotene) foam, 0.1%, to treat acne vulgaris in patients 12 years of age and older. North America Dermatology vice president Jean-Christophe May said, "Stiefel is ...
Tags: Stiefel NDA, Tazarotene foam, Medicine
The British Standards Institution (BSI), a notified body under the Medical Device Directive, has awarded a CE mark for the expanded clinical indication for Harvest Technologies' SmartPReP 2 Bone Marrow Aspiration Concentration System (BMAC ...
LEO Pharma Taclonex (calcipotriene and betamethasone dipropionate) topical suspension, 0.005%/0.064% has won FDA approval for body plaque psoriasis. With the approval, the only once-daily, steroid-containing topical treatment is now ...
Tags: body plaque psoriasis, Medicine
The USFDA has approved Abbott's Humira (adalimumab) for the treatment of adult patients with moderate to severe Ulcerative Colitis (UC) when certain other medicines have not worked well enough. Humira, which works by inhibiting tumour ...
Tags: FDA, Abbott Humira, Ulcerative Colitis
Sunovion Pharmaceuticals has submitted two supplemental new drug applications (sNDAs) to the FDA seeking approval for the use of LATUDA (lurasidone HCl) as monotherapy and adjunctive therapy in adult patients with depressive episodes ...
Tags: FDA, sNDA, atypical class of drugs, bipolar depression
Janssen Research and Development has received the Priority Review for the supplemental New Drug Application (sNDA) for ZYTIGA from US Food and Drug Administration (FDA). Zytiga (abiraterone acetate) is administered in combination with ...
Tags: sNDA, priority review, FDA
The US Food and Drug Administration (FDA) has approved ZALTRAP (ziv-aflibercept) injection to be used in combination with 5-fluorouracil, leucovorin, irinotecan (FOLFIRI) to treat patients with metastatic colorectal cancer (mCRC) that is ...
Tags: Zaltrap Injection, Medicine