FDA Archives - Page 5 of 19 - Lets Talk Health

FDA approves Ironwood constipation drug

08/30/2012 majac Your Health Matters

(Reuters) – The Food and Drug Administration on Thursday approved Ironwood Pharmaceuticals Inc’s drug to treat chronic constipation and irritable bowel syndrome with constipation for use in adults. The drug, linaclotide, will be sold under the brand name Linzess and carry a boxed warning that it should not be used in patients 16 or younger, the agency said. An estimated 63 million people suffer from chronic constipation, according to the National Institutes of Health. Additionally, an estimated 15. …

Drug Administration, FDA, Ironwood Pharmaceuticals Inc, National Institutes

FDA recalls another CareFusion infusion pump

08/22/2012 majac Your Health Matters

(Reuters) – U.S. health regulators announced a recall of CareFusion’s Alaris pump module Model 8100, saying a potential keypad malfunction in the infusion pump could cause serious injury or death. The U.S. Food and Drug Administration said the affected pump modules, used for delivering a variety of fluids, drugs and blood products to patients, were manufactured between October 2011 and February 2012. The FDA classified the action as a Class I recall on its website, meaning that the defective units could cause serious harm to a patient’s health. …

Drug Administration, FDA, health

FDA extends review time for NPS Pharma’s bowel drug by three months

08/13/2012 majac Your Health Matters

(Reuters) – NPS Pharmaceuticals Inc said U.S. health regulators pushed back the review date for the marketing approval application for its experimental bowel drug by three months. U.S. Food and Drug Administration will now decide on the approval of Gattex on December 30, 2012, the drugmaker said in a statement. The FDA extended the date to provide time for a full review of the submission, NPS Pharmaceuticals said. The application was accepted by the agency in January 2012. …

Drug Administration, FDA, health

FDA approves Talon’s Marqibo for rare leukemia

08/09/2012 majac Your Health Matters

WASHINGTON (Reuters) – The Food and Drug Administration said on Thursday it has approved Talon Therapeutics Inc’s Marqibo treatment for adults with a rare form of leukemia known as Philadelphia chromosome negative acute lymphoblastic leukemia. The drug, a targeted version of generic chemotherapy drug vincristine, will be the first commercial product for Talon. The company is majority-owned by Warburg Pincus and Deerfield Management, but shares accounting for a minority portion of its equity trade over-the-counter and were down 5 percent in afternoon trading. …

Drug Administration, FDA

23andMe seeks FDA approval for personal DNA test

07/30/2012 majac Your Health Matters

Genetic test maker 23andMe is asking the Food and Drug Administration to approve its personalized DNA test in a move that, if successful, could boost acceptance of technology that is viewed skeptically by leading scientists who question its usefulness.

DNA, Drug Administration, FDA

hCGTreatments / Diet Doc Announces What "FDA Approved" Means in Weight …

07/27/2012 majac Diets & Weight Loss

hCGTreatments / Diet Doc Weight Loss announces the difference between having a weight loss pill "FDA approved" and weight loss supplements which do not require FDA approval. According to the FDA's website, the FDA is also responsible for advancing the …
See all stories on this topic »

FDA, Weight Loss

As far as weight–loss quick fixes go, consumers on their own

07/26/2012 majac Your Health Matters

But most diet pills haven't been approved for safe weight loss by the Food and Drug Administration, and products often make unsubstantiated scientific claims, consumer experts say. Also, dietary supplements don't need to register with the FDA nor …
See all stories on this topic »

USA TODAY

Drug Administration, FDA

FDA gives new weight–loss drug OK

07/26/2012 majac Diets & Weight Loss

Within the past month, the U.S. Food and Drug Administration approved two weight–loss drugs, the first such drugs to be approved by the administration in more than a decade. But neither are standalone treatments, said JoeBob Kirk, a bariatric physician …
See all stories on this topic »

Drug Administration, FDA, OK

FDA approves another weight loss pill called Qsymia

07/21/2012 majac Diets & Weight Loss

A second weight loss pill has been approved by the Food and Drug Administration in two months. The drug named Qsymia is … to control and reduce weight. Dr. Tim Garvey from the University of Alabama, Birmingham, thinks that relatively better …
See all stories on this topic »

Drug Administration, FDA

FDA approves Novartis drug Afinitor for breast cancer

07/20/2012 majac Your Health Matters

(Reuters) – The U.S. Food and Drug Administration on Friday approved Novartis AG drug Afinitor to treat women with a certain type of breast cancer. The drug is the first in a class known as mTOR inhibitors to be approved for post-menopausal women with advanced hormone-receptor positive, HER2-negative breast cancer. The European Medicines Agency in June also endorsed Afinitor as a breast cancer treatment. …

Drug Administration, FDA

Anticipated new weight loss drug gains FDA approval

07/19/2012 majac Diets & Weight Loss

Remember my Info. Obesity is an American epidemic. Advertisement. In a press release dated July 17, 2012, the Food and Drug Administration announced the approval of a new weight loss drug, geared toward individuals who are not only overweight, but have …
See all stories on this topic »

Examiner.com

Drug Administration, FDA

FDA approves diet drug that could lead to 10% weight loss

07/18/2012 majac Diets & Weight Loss

This is the second medication to fight obesity that the Food and Drug Administration has approved this summer after going for more than a decade without approving a diet drug. Qsymia from Vivus Inc. of … “Its strength is not just the weight loss, but …
See all stories on this topic »

Drug Administration, FDA, Vivus Inc

« 1 … 3 4 5 6 7 … 19 »