Merck (NYSE: MRK), known as MSD outside the United States and Canada, have announced that the U.S. Food and Drug Administration (FDA) has approved new labeling for ISENTRESS® (raltegravir) Film-coated Tablets, Merck's integrase inhibitor for the treatment of HIV-1 infection in adult patients as...
The US FDA have notified the Austrian biotech company Activartis that Orphan Drug Designation (ODD) has been granted for its innovative Cancer Immunotherapy AV0113. The ODD applies specifically to the use of AV0113 for the treatment of malignant glioma, a very aggressive type of brain cancer...
The FDA has approved the morning after pill for women of any age as an over-the-counter medication and with no point-of-sale restrictions. Over-the-counter (OTC) means that no prescription is required. The FDA said the approval is for "women of child bearing age potential", i.e. any female who...
Fecal transplants have been in the news in the last few years as a novel way to treat powerful, debilitating bacterial infections, namely those of people infected with the bacterium*C. difficile.*The FDA is has introduced strict new regulations for the procedure, however, which is causing some...
Federally mandated labeling laws-required by the U.S. Food and Drug Administration—are in place so that we shoppers don't accidentally scorch our skin. The sunscreens will now have to be clear: do they protect skin cancer? Do they protect against sunburn? Are they water-resistant? More »...
Blue light special in Washington! The head of the U.S. Food and Drug Administration would like to remind Congress that Americans are getting "a true bargain" on the agency's services. More »
Ha! FDA Chief Calls Agency A “True Bargain” is a post from Blisstree - Get tips on healthy living, work...
There's good news, ladies: A new type of birth control pill has been approved by the FDA! Quartette has a combination of*levonorgestrel/ethinyl estradiol and ethinyl estradiol and can help prevent breakthrough bleeding. More »
No More Breakthrough Bleeding? FDA Approves Quartette, A New Form Of...
The U.S. Food and Drug Administration cautioned doctors and hospital staff on Monday about a nationwide recall of all medications made by a New Jersey compounding pharmacy because of a potential mold contamination. The recalled medications from Med Prep Consulting Inc. included many pain...
Kadcyla (ado-trastuzumab emtansine), a new medication for the treatment of HER2-positive, metastatic breast cancer, has been approved by the Food and Drug Administration (FDA), USA. Metastatic, also known as late-stage, means the cancer has spread to other parts of the body. HER2, a protein...
Showcasing its leadership position in pacing technologies, Medtronic, Inc. (NYSE: MDT), has announced the U.S. Food and Drug Administration (FDA) approval and U.S. launch of its Advisa DR MRI™ SureScan® pacing system. The Advisa MRI system is Medtronic's second-generation MR-Conditional...
Novo Nordisk is the star of today's health news right now, because the Food and Drug Administration didn't approve two of their new diabetes drugs as expected. But practically all headlines and articles are focused on one thing: What this means for the value of Novo Nordisk shares. Am I crazy...
Stanmore Implants ('Stanmore'), specialists in the design and manufacture of patient specific and modular orthopaedic implants, announced today that it has received 510(k) clearance from the US Food and Drug Administration (FDA) to market its Sculptor Robotic Guidance Arm™ ("Sculptor RGA™") for...
In an effort to treat and identify Alzheimer's patients early on during the disease, the FDA says it may relax the guidelines on Alzheimer's early-stage trials. The Agency has issued a proposal designed to help researchers and developers find new treatments for patients before the onset of overt...
New restrictions should be applied to widely used narcotic painkillers, because of an alarming increase in addiction and overdose deaths, an FDA Drug Safety and Risk Management Advisory Committee (The Panel) recommended. The Drug Safety Advisory Panel voted 19 to 10, recommending that drugs...
It's tempting to laugh at the conclusion of a new study from the U.S. Food and Drug Administration, which basically amounts to: Reading food labels is hard, y'all. But reading food labels is hard ... More »
FDA Study Confirms What We All Know: Food Labels Confuse The Bejeezus Out Of People is a...
Having a severe headache is a horrible feeling: you can’t bandage it up or put pressure on the wound or inject some novocaine to help yourself sleep. Migraines can affect your work, social life, mental health and several other aspects … More »
Looking For Relief From Severe Headache Pain? FDA...
Manufacturers of sleeping pills with an active ingredient called zolpidem are being forced by the U.S. Food and Drug Administration (FDA) to reduce the current recommended dose of the medications. This measure comes following new evidence showing that the zolpidem blood levels of some people the...
The US Food and Drug Administration (FDA) has approved a new 4-strain seasonal flu vaccine from GlaxoSmithKline plc (GSK), the company announced on Monday. Fluarix Quadrivalent is approved for use in adults, plus children aged 3 and over, to protect them from disease caused by influenza virus...
The FDA has approved Flucelvax, the first seasonal vaccine licenced in the USA made with the use of cultured animal cells, instead of fertilized chicken eggs. The FDA (Food and Drug Administration) has approved Flucelvax to protect patients aged at least 18 years from seasonal flu. Flucelvax's...
Cook Medical has received U.S. Food and Drug Administration (FDA) marketing approval for the first devices in its Zilver® PTX® Drug-Eluting Peripheral Stent portfolio, company officials reported today. It's the first time the FDA has approved a drug-eluting stent to treat blockages in a...