Genzyme, a Sanofi company, has received a refuse to file letter from the US Food and Drug Administration (FDA) in response to the supplemental Biologics License Application (sBLA) for the approval of Lemtrada (alemtuzumab) as a treatment ...
Tags: Genzyme, Lemtrada marketing, FDA
Sapheon, a developer of technologies for the treatment of vascular diseases, has completed the first closing in its $18.5m Series B Preferred equity offering. The company said the proceeds from the Series B offering will be used to ...
The USFDA has approved Watson Laboratories' abbreviated new drug application (ANDA) for lidocaine topical patch 5%, the generic equivalent to Endo's Lidoderm. Lidocaine is an amide-type local anesthetic agent and is suggested to ...
Indiana-based Chamberlain Farm Produce is voluntarily recalling its cantaloupes from the 2012 growing season as they may be contaminated with Salmonella,according to the US Food and Drug Administration(FDA). This recall follows the ...
Tags: cantaloupes, FDA, Salmonella
American biotechnology firm XOMA has obtained orphan drug designation by the US Food & Drug Administration (FDA) for its IL-1 beta modulating antibody 'Gevokizumab', which treats non-infectious intermediate, posterior, pan-uveitis, or ...
Tags: American biotechnology, XOMA, orphan drug, FDA
Spence,a smoked salmon firm based in Massachusetts,US,is recalling salmon products as they may be contaminated with Listeria monocytogenes,according to the US Food and Drug Administration(FDA). The products affected by this recall are ...
Tags: FDA, salmon products, Listeria monocytogenes
Toumaz has completed the acquisition of Frontier Silicon. Toumaz,a developer of specialist medical sensors and low power wireless chips,announced in July it had agreed to acquire Frontier Silicon,the digital radio chipset developer for ...
Tags: Toumaz, completed the acquisition of Frontier Silicon, 32.3m pounds
AbGenomics International, a biopharmaceutical company, has obtained FDA agreement on Its Phase 2 clinical trial plans of the novel autoimmune therapeutic candidate, AbGn-168H. The current Phase 2 AbGn-168H trial will be a multicenter, ...
Tags: FDA approval, psoriatic, clinical trial, pharmaceutical product
The US Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) of Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company for Tradjenta (linagliptin) tablets for use as add-on therapy to insulin. ...
Tags: FDA, sNDA, pharmaceutical product, clinical development
Alfa Wassermann Diagnostic Technologies has unveiled its ACE Axcel Clinical Chemistry system, designed for use in physician office labs to process up to 285 tests per hour with both photometric and potentiometric detection technologies. ...
Tags: ACE Axcel Clinical Chemistry system, ACE Axcel system, Medical devices
Crane ChemPharma Flow Solutions, Saunders offers customers its new EX Diaphragm, designed to withstand long periods of operation without damage or deterioration due to elevated temperatures. Its performance characteristics make the EX ...
Tags: market view, crane
Tanimura&Antle,a produce supplier based in California,US,is voluntarily recalling romaine lettuce that was distributed to 19 states in the US as well as Puerto Rico and Canada over fears of possible E.coli contamination. The recall ...
Tags: romaine lettuce, E.coli, plastic bag
The US Food and Drug Administration (FDA) has cleared CryoPen 's new GY2 Cryosurgical system for use in gynecology. The GY2 Cryosurgical system, which delivers treatment at -105° Celsius, facilitates medical professionals to ablate ...
Tags: GY2 Cryosurgical System, Health, gynecology
UK-based Kimal has entered into an agreement to distribute Actuated Medical's TubeClear system throughout Europe, the Middle East, and North Africa. The FDA and CE marked TubeClear system incorporates reusable control boxes and single-use ...
Tags: TubeClear system, mechanical system, decompression tubes
The US Food and Drug Administration (FDA) has granted orphan drug designation to GeNO for use of inhaled nitric oxide (NO) in treatment of persistant pulmonary hypertension of the newborn (PPHN). The orphan drug designation was granted ...
Tags: orphan drug designation, FDA, persistant pulmonary hypertension