NeuroMetrix, a US-based medical device company, has received 510(k) approval from the US Food and Drug Administration (FDA) for its transcutaneous electrical nerve stimulator, called Sensus Pain Management System. Sensus Pain Management ...
Tags: medical device, Pain Management
A combination of GlaxoSmithKline’s GSK744 and J&J’s TMC278 monthly injection therapy, designed to evaluate its potential to control HIV, is currently being tested. Results of a study, which was conducted on 40 HIV-negative ...
Tags: Injection Therapy, Medicine
The US Food and Drug Administration (FDA) has cleared Theravance's Vibativ (telavancin) for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP). With a dual mechanism of action, the bactericidal, ...
Tags: Health&Medicine, FDA, US
The USFDA has accepted Pfizer's supplemental new drug application (sNDA) to expand labeling of rheumatoid arthritis medication Xeljanz (tofacitinib citrate) to include inhibition of structural damage progression. The data from ORAL Start ...
Tags: FDA, Pfizer sNDA, Xeljanz Labeling
Raptor Pharmaceutical, a biopharmaceutical company focused on developing and commercializing life-altering therapeutics, has announced the commercial availability of Procysbi for nephropathic cystinosis patients in the US. The US FDA ...
Tags: US, Health&Medicine, Raptor's Procysbi
The US Food and Drug Administration (FDA) has accepted the new drug application (NDA)from DURECT, a specialty pharmaceutical company, for its Posidur (Saber-Bupivacaine) investigational candidate. Designed to offer up to three days of ...
CryoLife, a US-based tissue processing and medical device company, has secured conditional US FDA approval of its Investigational Device Exemption (IDE) for PerClot. A hemostat made of absorbable polysaccharide granules, PerClot is ...
Tags: Cryolife, Trials of Perclot
Specialty pharmaceutical company TherapeuticsMD has obtained investigational new drug (IND) application clearance from the US Food and Drug Administration (FDA) for vaginal estradiol suppository, TX12-004HR. The IND acceptance will allow ...
The US Food and Drug Administration (FDA) has urged medical device manufacturers to boost their security protection systems against cyber attacks, which could compromise the safety and privacy of patients. According to the agency's safety ...
Tags: Medical Devices, Cyber Attacks
Teleflex, a US-based firm that provides medical devices for critical care and surgery, has won US FDA 510(k) clearance for its Arrow NextStep retrograde femoral length dialysis catheter. The catheter adds to the company's existing ...
Tags: Teleflex, Dialysis Catheters
The US FDA has cleared Sanofi Pasteur's supplemental biologics license application (sBLA) licensing four-strain influenza vaccine, Fluzone Quadrivalent, for broad age range of children and adults. As the first and only four-strain ...
Tags: Influenza Vaccine, Medicine
The US Food and Drug Administration (FDA) is evaluating the safety of Intuitive Surgical's robotic surgical devices. Currently, the agency is studying a small group of surgeons who use the surgical device, which is used in over 2,000 ...
The US Food and Drug Administration (FDA) has approved GlaxoSmithKline's Tafinlar (dabrafenib) and Mekinist (trametinib) as single-agent therapies for unresectable or metastatic melanoma with BRAF V600E mutation. Tafinlar is not indicated ...
The US Food and Drug Administration (FDA) has given its approval for the marketing of Roche's Cobas Integra 800 Tina-quant HbA1cDx assay for the diagnosis of diabetes. Presently available in the market, the HbA1c tests, or A1c tests are ...
Tags: Diabetes Diagnosis, Medicine
The US FDA has approved Algeta's Xofigo (radium-223 dichloride) injection for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. Xofigo is the first ...