The US Food and Drug Administration (FDA) has approved GlaxoSmithKline's (GSK) use of Mekinist (trametinib) in combination with Tafinlar (dabrafenib) for the treatment of patients with unresectable melanoma or metastatic melanoma with BRAF ...
Tags: FDA, Combination Drug
Cardica, a medical device company, has received 510(k) approval from the US Food and Drug Administration (FDA) for its MicroCutter Xchange 30 device and blue staple cartridge for medium thickness tissue. The company has designed the ...
Tags: Cardica, medical device
Radius Medical has announced the US Food and Drug Administration (FDA) approval and product introduction of its new Prodigy support catheter. The company has designed the Prodigy support catheter for providing back up support to the ...
Tags: Radius Medical, Medicine
Globus Medical, a musculoskeletal implant manufacturer, has announced the acquisition of Excelsius Surgical, the developer of a next generation surgical robotic positioning platform for spine, brain and therapeutic markets. The company ...
Tags: Globus Medical, Medicine
Denmark-based pharmaceutical company ALK-Abello has announced that the FDA Allergenic Products Advisory Committee of the US Food and Drug Administration (FDA) will meet on 28 January 2014 to discuss the biologic license application (BLA) ...
Integra LifeSciences, has announced the completion of patient enrollment in a pivotal clinical trial designed to assess the safety and effectiveness of Integra dermal regeneration template in the treatment of diabetic foot ulcers. Integra ...
US-based biotechnology company United Therapeutics has obtained an approval from the US Food and Drug Administration (FDA) for the Orenitram (treprostinil) extended-release tablets, indicted for the treatment of pulmonary arterial ...
Tags: Extended-Release Tablets, Medicine
Belgium-based FLUIDDA has developed proprietary functional respiratory imaging (FRI) technology that provides a unique entry point into personalized medicine for respiratory diseases. FRI reduces significantly the number of patients ...
The Netherlands-based Royal Philips has obtained 510(k) approval from the US Food and Drug Administration (FDA) for the spectral breast density measurement application for use with its MicroDose SI full-field digital mammography (FFDM) ...
Israel-based medical device company Brainsway has obtained an investigational device exemption (IDE) clearance from the US Food and Drug Administration (FDA) to initiate a clinical trial for assessing the efficacy of its Deep TMS ...
Regenesis Biomedical has announced that the US Food and Drud Administration (FDA) has approved the removal of the contraindication for use of the company's Provant therapy system in patients with metallic implants in the area of treatment. ...
Tags: Metallic Implants, FDA
The US Food and Drug Administration (FDA) has approved GlaxoSmithKline (GSK) and Theravance's Anoro Ellipta as a once-daily, long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease ...
The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have announced the launch of a joint initiative to share information on inspections of bioequivalence studies submitted in support of generic drug approvals. ...
Tags: Generic Drug, Medicine
Oticon Medical, a manufacturer of bone anchored hearing systems, has obtained 510(k) approval the US Food and Drug Administration (FDA) to market its Ponto Plus bone anchored sound processors in regular version (down to a hearing loss of ...
Tags: Oticon Medical, Ponto Plus Bone
Navidea Biopharmaceuticals has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) for the approval to market and sale Lymphoseek Injection for sentinel lymph node (SLN) detection in patients ...