The US Food and Drug Administration (FDA) has approved InfraScan's noninvasive handheld brain hematoma detector for use by civilian and military medical professionals to triage head trauma patients. Featuring a disposable patient ...
Tags: FDA, Infrascan Noninvasive Handheld, Brain Hematoma Detector
Biogen Idec and Elan are seeking approvals from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) for first-line use of Tysabri (natalizumab) in anti-JCV antibody negative patients with multiple sclerosis (MS). ...
The USFDA has accepted for filing Astellas Pharma's supplemental new drug application (sNDA) for Tarceva (erlotinib) tablets for a genetically distinct form of advanced lung cancer. Astellas is seeking approval to use Tarceva as the ...
On these short winter days, some people might find themselves eyeing caffeinated energy drinks for a little boost. But perk up your ears: Emergency room visits for problems related to energy drinks have risen sharply, particularly for ...
Tags: caffeinated energy drinks, healthcare, drug related hospital emergency
CardioFocus will complete full patient enrollment in a US pivotal clinical trial of its HeartLight catheter ablation system in 2013. The 350 patient-based trial, which is evaluating and comparing the safety and efficacy of the company's ...
A Consumer Reports article on arsenic in rice continues to impact consumer confidence and sales of some rice products. Consumer Reports released the arsenic article on Sept. 19, along with a very well coordinated media campaign, citing ...
Tags: rice products, arsenic in rice, rice
Santarus has obtained FDA approval for ulcerative colitis therapy, Uceris (budesonide) extended release tablets. A 9mg dose tablet is approved for administration once a day in adult patients with ulcerative colitis for up to eight weeks. ...
BSD Medical has sold its MicroThermX microwave ablation systems and antennas to ADA Medikal, a medical specialty distributor, in Turkey. The sale of multiple MicroThermX systems and antennas forms a part of a distribution agreement signed ...
Tags: BSD Medical, MicroThermX microwave ablation systems, ADA Medikal, Turkey
The US Food and Drug Administration (FDA) has cleared the use of Hologic's amplified nucleic acid assay on the company's fully-automated Panther system. Using endocervical or vaginal swabs and specimens, collected in Hologic's ThinPrep ...
Tags: FDA, Hologic, Panther system, Trichomonas vaginalis assay
The term "dry wine" has a new meaning at Vincor International's Quebec bottling operation since the conveyor line eliminated soap-and-water lubrication by installing System Plast NG conveyor chain and Nolu-S wear track from Power ...
Tags: dry wine, bottling operation, Winemaker
Canola oil is generally recognized as safe (GRAS) for use as an ingredient in infant formula marketed in the US. Recently, the Food and Drug Administration (FDA) announced that it has no questions in response to a notice that was filed ...
Tags: Canola oil, GRAS, ingredient, infant formula, US
US-based Island Delights is recalling 492 bags of its Coconut Haystack Candy as it may contain milk that is not mentioned on the product label, according to the Food and Drug Administration (FDA). The products subject to recall include ...
Tags: US, Island Delights, Coconut Haystack Candy, FDA
The US Patent and Trademark Office (USPTO) has granted a notice of allowance (NOA) to biopharmaceutical company Amarin for its claims related to Vascepa and FDA-approved MARINE indication. The NOA, which is issued based on patent ...
Tags: NOA, Vascepa capsules, biopharmaceutical
Telik has announced notification of FDA orphan drug designation to ezatiostat HCL (Telintra) for the treatment of myelodysplastic syndrome (MDS). The novel inhibitor of the enzyme glutathione S-transferase P1 1,Telintra activates Jun ...
Tags: orphan drug, ezatiostat HCL, drug
The US FDA has approved Cangene's Varizig for post-exposure prophylaxis of varicella in patients including immunocompromised children, newborns and pregnant women. The hyperimmune product that contains antibodies specific for the ...
Tags: FDA, hyperimmune product, Varicella Zoster Immune Globulin, U.S.A