The U.S. Food and Drug Administration (FDA) has given its green signal to Eli Lilly's angiogenesis inhibitor Cyramza (ramucirumab) to treat stomach cancer (in advanced stage) or gastroesophageal junction adenocarcinoma, a form of cancer located in the region where the esophagus joins the stomach. “Although the rates of stomach cancer in the United States have decreased over the past 40 years, … [Read more...]
FDA : Sarepta’s Eteplirsen drug for treating Duchenne muscular dystrophy
The Food & Drug Administration (FDA) has given ray of hope to Sarepta Therapeutics by agreeing to consider its experimental drug for Duchenne muscular dystrophy for accelerated approval. Sarept’s eteplirsen is a new intravenous drug known to stabilize the symptoms of a rare and fatal form of muscular dystrophy known as Duchenne. Expressing confidence in positive FDA decision, Sarepta … [Read more...]
FDA gives green signal to Ragwitek to treat pollen allergies, hay fever
The Food and Drug Administration (FDA) has given its green signal to Ragwitek, an allergen extract, to treat short ragweed pollen induced allergic rhinitis or hay fever. The drug, administered under the tongue, helps in treating hay fever (with or without conjunctivitis) in those in age group 18 and 65. Ragwitek contains an extract from short ragweed (Ambrosia artemisiifolia) pollen. One … [Read more...]
Congressional report bats for stringent regulation of Electronic Cigarettes
Electronic cigarettes are considered as a good way to quit smoking or a better and healthy alternative to traditional cigarettes. But their rampant use among the Americans especially the teens have raised concerns among the lawmakers and researchers as they are finding health woes related to it. A new Congressional report has mentioned many of the same concerns about these modern cigarettes as … [Read more...]
FDA gives nod to user-friendly auto-injector Evzio for heroin overdose antidote
Taking note of the rise in deaths from heroin and other drug overdoses, the Food and Drug Authority (FDA) has given its approval to a new hand-held medical device called Evzio, that delivers a life-saving heroin and painkiller antidote called naloxone. The agency has approved the prescription treatment after just 15 weeks under priority status. The hand-held auto-injector is designed in such … [Read more...]
FDA gives approval to Stallergenes’ immunotherapy drug Oralair
The US Food and Drug Administration (FDA) has given green signal to Stallergenes’ immunotherapy drug Oralair for treating grass allergies. It is the first oral immunotherapy pill for treating grass allergies that has been approved in the United States. The drug harnesses the immune system to make you free of allergies and is an alternative to current injectable treatments. The pill is a … [Read more...]
FDA advisory panel recommends two new antibiotics Dalvance, Sivextro
The advisory committee of US Food and Drug Administration (FDA) has given its nod to two new antibiotics Durata Therapeutics's Dalvance and Cubist Pharmaceuticals's Sivextro. The anti-infective drugs advisory committee of FDA unanimously recommended the approval of two new antibiotics on Monday. One of the panel member Thomas A. Moore said, "It's (Dalvance) a highly effective drug, as … [Read more...]
Novartis plans to approach FDA as its Plaque psoriasis drug clears trial
Swiss drugmaker Novartis on Saturday said that its experimental drug secukinumab proved to be more effective than Enbrel at clearing psoriasis in a phase III clinical trial. According to the firm, the drug showed good results in a two late-stage clinical trials when used by patients suffering from moderate-to-severe plaque psoriasis. The study findings were presented at the American Academy … [Read more...]
‘Cefaly’ headband-like device to prevent migraines gets FDA nod
The US Food and Drug Administration (FDA) has given green signal to first medical device that aims to treat migraine headaches. A nerve-stimulating headband received the approval by FDA as the first medical device to prevent migraine headaches. According to the FDA, the device provides a new trustable option for patients having unbearable migraine medications. The new migraine prevention … [Read more...]
Regeneron and Sanofi’s new cholesterol drug under FDA scanner
Sensing the probable side effects of cholesterol drug, Sanofi, the Food and Drug Administration (FDA) has asked Regeneron Pharmaceuticals Inc and Sanofi SA to assess the neurocognitive side effects of their experimental medicine. FDA says, "The agency is aware of concerns raised with neurocognitive adverse events and other lipid-lowering therapies, including statins, and as part of our … [Read more...]
