The FDA Arthritis Advisory Committee has recommended the approval of Pfizer's Tofacitinib for adult patients with moderately to severely active rheumatoid arthritis (RA). The recommendation will be considered by the FDA in its review of ...
Tags: RA, tofacitinib, rheumatoid arthritis
Cutting Edge Concessions is recalling Shake'Ems seasoning cups in the US, as the products contain milk as well as red 40 food color, which is not declared on the label. People who have an allergy or severe sensitivity to milk can ...
Tags: not declared on the label, allergy or severe sensitivity to milk
Mevion Medical Systems, a radiation therapy company, has received FDA 510(k) clearance for its MEVION S250 Proton Therapy System. The MEVION S250, powered by a patented TriNiobium Core, provides the delivers precise and intense proton ...
Tags: Mevion Medical, FDA 510(k)clearance, MEVION S250, Proton Therapy System
Lupin Pharmaceuticals has gained FDA approval for its Norgestimate and Ethinyl Estradiol tablets, 0.18mg/0.025mg, 0.215mg/0.025mg, and 0.25mg/0.025mg. Norgestimate and Ethinyl Estradiol tablets are indicated for the prevention of ...
Tags: Lupin Pharmaceuticals, norgestimate and ethinyl estradiol tablets
LDR has secured an approval letter from the US Food and Drug Administration (FDA) for its low-profile cervical intervertebral disc. The Mobi-C disc, which is a metal and polyethylene mobile bearing prosthesis, is a cervical implant ...
Tags: LDR, FDA, approval letter, cervical intervertebral disc, Mobi-C disc
Medgenics has filed an investigational new drug (IND) application with the FDA to initiate a Phase IIb multi-center, 100-patient clinical trial. The trial is designed to evaluate the safety and efficacy of sustained erythropoietin (EPO) ...
Medtronic has announced the US launch of the ACD instrument set, designed for implanting the BRYAN cervical disc system. The FDA-approved instrument is designed for the treatment of single-level cervical disc disease (radiculopathy and/or ...
Tags: Medtronic, BRYAN cervical disc system, FDA-approved instrument
Mylan has been sued jointly by Pfizer,Wyeth Pharmaceutical,Wyeth LLC and PF Prism regarding the filing of an abbreviated new drug application (ANDA) with the US food and drug administration (FDA) for desvenlafaxine succinate ...
Tags: Mylan, desvenlafaxine succinate extended-release tablets, MDD
The US Food and Drug Administration (FDA) has granted de novo petition to market Nanosphere's gram-positive blood culture nucleic acid test (BC-GP) on the automated sample-to-result Verigene system. Single automated BC-GP test detects ...
Tags: Nanosphere, FDA, BC-GP test, Verigene system
Roche Group member, Genentech has received US Food and Drug Administration (FDA) official approval of priority review designation for trastuzumab emtansine Biologics License Application (BLA). Trastuzumab Emtansine is designed to treat ...
The FDA has granted orphan drug designation for Andromeda Biotech's DiaPep277 to treat type 1 diabetes (T1D) patients with residual beta cell function. The orphan drug status offers seven years marketing exclusivity from the time of ...
Tags: DiaPep277, type 1 diabetes, T1D, residual beta cell
Actavis Group, a generic pharmaceuticals company, has gained FDA approval for Ropinirole extended-release tablets, 2mg, 4mg, 6mg, 8mg and 12mg. The company has started distribution of the generic version of GlaxoSmithKline's Requip XL. ...
The US Food and Drug Administration (FDA) has accepted Avanir Pharmaceuticals' investigational new drug (IND) application for the study of AVP-923, an investigational drug for the treatment of agitation in patients with Alzheimer's disease. ...
Tags: AVP-923, Alzheimer's disease, IND
The US Food and Drug Administration (FDA) has granted 510(K) approval to KFx Medical's AppianFx Tissue Fixation Anchor. The 5mm AppianFx Tissue Fixation Anchor is designed to reattach tissue to bone in foot and ankle procedures. Seaview ...
Tags: FDA, 510(K)approval, KFx Medical's AppianFx Anchor, implants
The Antiviral Drugs Advisory Committee of the FDA has recommended the approval of Gilead's Quad to treat HIV-1 infection in treatment-naive adults. The Quad is a complete single tablet regimen of elvitegravir, cobicistat, emtricitabine ...
Tags: gilead's quad, HIV-1, quad NDA