By Russ Daly, DVM, DACVPM Recently, livestock producers and veterinarians have been hearing about changes coming in the way antibiotics are used in food animals. In mid-December, the Food and Drug Administration (FDA) published a final ...
US-based Medac Pharma has reported the US Food and Drug Administration (FDA) acceptance of a new drug application (NDA) for its lead product candidate, MPI-2505, a subcutaneous injectable methotrexate (MTX) in a ready-to-use injection ...
Teva Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for its supplemental new drug application (sNDA) for three-times-a-week COPAXONE 40mg/mL, a new dose of COPAXONE. COPAXONE (glatiramer acetate ...
Solos Endoscopy, a provider of healthcare instruments to hospitals across the US, announce that the company has received its ISO 13485:2003 Certification from TUV SUD America. The certification to ISO 13485:2003 will in turn allow Solos ...
Tags: TUV SUD, FDA, ISO Certified, MammoView
Sapheon has announced the Health Canada approval for its VenaSeal sapheon closure system, designed to treat venous reflux disease (varicose veins). VenaSeal features a specially formulated medical adhesive that closes the saphenous vein. ...
Benvenue Medical, a medical device company, has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its Kiva VCF treatment system for the reduction and treatment of spinal fractures. The FDA marketing clearance is ...
AtheroMed has obtained marketing approval from the US Food and Drug Administration (FDA) for its Phoenix atherectomy system for treating peripheral artery disease (PAD). Phoenix atherectomy system is a peripheral atherectomy catheter ...
Tags: FDA, pPAD, debulked material, Archimedes Screw
BioAlliance Pharma, an innovative Company dedicated to the development of orphan oncology, announced today that Validive (clonidine Lauriad) received a Fast Track designation from the US Food and Drug Administration (FDA) for the prevention ...
Tags: FDA, BioAlliance Pharma, disease, Validive
US-based Pressure Products has obtained the US Food and Drug Administration (FDA) approval for its SafeSept needle free transseptal guidewire for use with any introducer system when crossing the interatrial septum. SafeSept, which assists ...
Tags: FDA, Dr James McCready, Royal Sussex County, SafeSept
Venaxis, a US-based in vitro diagnostic firm, has completed the patient enrollment in its pivotal clinical study of the APPY1 test in the US. The APPY1 test, a unique appendicitis test, has projected high sensitivity and negative ...
Tags: Venaxis, APPY1, Steve Lundy, FDA
CEL-SCI Corporation has received approval from the Medicines and Medical Device Agency of Serbia to begin enrollment of subjects in its Phase III Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatment ...
To help dairy companies understand the next proposed rule to be released under the Food Safety Modernization Act (FSMA), IDFA will host a webinar on “Sanitary Food Transportation” on February 14, 1:30 - 3:00 p.m. Eastern time. ...
Tags: Food Safety, dairy companies
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: States Consider Labels for Genetically Modified Foods A number of states are considering laws requiring labels on food products that ...
Tags: FDA, Malta Goya, Health, AP Report
Hi-Tech Pharmacal Co., Inc. (NASDAQ:HITK), a specialty pharmaceuticals company, announced today that the US Food and Drug Administration, (FDA) granted final approval for the Company's Abbreviated New Drug Application, (ANDA) for Bromfenac ...
The New York Times: Health Care Reform Survives A Lawsuit A long-shot lawsuit that could have damaged the effectiveness of health care reform got a well-deserved brushoff from a federal district judge on Wednesday. The suit was brought ...
Tags: New York Times, Alemtuzumab, Maternity Leave, FDA