Eli Lilly and Boehringer-Ingelheim said that the Food and Drug Administration didn't approve their diabetes treatment empagliflozin because of concerns about a facility where the drug will be made.
I’m the guy who looks down his nose at every new health trend and scoffs at those who embark on...
The Food and Drug Administration is warning that a stimulant used in treatments for the...
The U.S. Food and Drug Administration is implementing a plan to help phase out the use of...
This class action seeks to recover damages against the Company and certain of its officers and directors as a result of alleged violations of the federal securities laws.
Health officials are reporting four Tennessee cases of a rare infant illness that have been linked to parents refusing a routine Vitamin K shot for newborns.
For decades, if you asked your doctor what your odds were of suffering a heart attack, the answer would turn on a number: your cholesterol level. Now the nation's first new heart disease prevention guidelines in a decade take a very different approach...
The Shiga University of Medical Science has become the third Japanese institution to conclude that a clinical study report on Novartis Pharma K.K.'s Diovan blood pressure-lowering drug contained doubtful data and was inappropriate, largely because a Novartis employee participated in the study.
The FDA is recommending new restrictions on prescription medicines containing hydrocodone, the highly addictive painkiller that has grown into the most widely prescribed drug in the U.S. In a major policy shift, the agency said in an online notice Thursday that hydrocodone-containing drugs should be subject to the same restrictions as other narcotic drugs like oxycodone and morphine.
The Food and Drug Administration is appealing to dog and cat owners for information as it struggles to solve a mysterious outbreak of illness and deaths among pets that ate jerky treats. In a notice to consumers and veterinarians published Tuesday, the agency said it has linked illnesses from jerky pet treats to 3,600 dogs and 10 cats since 2007. About 580 of those pets have died.
The FDA has approved changes to the prescribing information of the immune-suppressing and anti-cancer drugs Arzerra (ofatumumab) and Rituxan (rituximab) to add new Boxed Warning information about the risk of reactivation of hepatitis B virus (HBV) infection.
The Food and Drug Administration is requiring stronger warning labels on prescription painkillers like OxyContin and Vicodin, in the government's latest attempt to reduce overdose deaths caused by the long-acting medications.
U.S. health regulators are warning doctors and women of child-bearing age that half-a-dozen medications used to treat migraine headaches can decrease children's intelligence if taken while their mothers are pregnant. The Food and Drug Administration said Monday that the drugs, including Depakote and Depacon, should never be taken by pregnant women for the prevention of migraine headaches.
President Barack Obama has proposed a $3.8 trillion budget for fiscal 2014 that aims to slash the deficit by $1.8 trillion over 10 years, raise taxes on the wealthy and trim popular benefit programs including Social Security and Medicare. The numbers do not reflect automatic annual spending cuts of 5 percent for domestic agencies and 8 percent for defense.
President Barack Obama is proposing a new investment into research to map the human brain in hopes of unlocking some of its mysteries, a senior administration official says. The president planned to propose a $100 million investment for next year during an announcement at the White House Tuesday morning, the official said.
Popping calcium and vitamin D pills in hopes of strong bones? Healthy older women shouldn't bother with relatively low-dose dietary supplements, say new recommendations from a government advisory group. Both nutrients are crucial for healthy bones and specialists advise getting as much as possible from a good diet.
Shares of Dynavax Technologies Corp. fell by more than a third after the company said the Food and Drug Administration won't approve its hepatitis B vaccine Heplisav unless Dynavax provides more information showing the drug is safe. Dynavax said the FDA is concerned about the possibility of "rare autoimmune events" in patients.
WASHINGTON (AP) — The FDA is warning consumers not to use an over-the-counter drug called Intestinomicina because the anti-diarrhea treatment contains a drug linked to life-threatening injuries.
WASHINGTON (AP) — The FDA is warning consumers about rare chemical burns reported by people using popular pain relief products like Bengay, Icy Hot and Flexall.
WASHINGTON (AP) — The Food and Drug Administration warned physicians and caregivers on Wednesday about the risks of giving the pain reliever codeine to children who have just had surgery to treat obstructive sleep apnea.
Drugs approved by the FDA but later re-called, such as Avandia and Vioxx, were the impetus for an Institute of Medicine committee report recommending proactive steps to continue monitoring drugs' safety after initial approval and throughout their time on the market.
The FDA is alerting healthcare professionals that another cancer drug, originating from a foreign source and purchased by U.S. medical practices, has been determined to be counterfeit.
An FDA panel on Thursday voted 12-2 that there is "substantial evidence to support approval of" Forest Laboratories and Almirall’s aclidinium to reduce complications stemming from chronic obstructive pulmonary disease (COPD).
An FDA panel on Thursday voted 7-4 to recommend approval of Chelsea Therapeutics’ Northera (droxidopa) for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure, dopamine beta hydroxylase deficiency or non-diabetic autonomic neuropathy.
Deaths from liver-destroying hepatitis C are on the rise, and new data shows baby boomers especially should take heed — they are most at risk.
A South African pharmaceutical manufacturer is fighting moves toward banning a painkiller that has been removed from the shelves in the U.S. and Europe because of fears it could harm the heart.
Study results published in the American Journal of Gastroenterology suggest that people who are prescribed a large number of antibiotics tend to have a higher risk of inflammatory bowel disease (IBD), Yahoo!Health reported.
The FDA said Monday that it "remains concerned" that drospirenone-containing oral contraceptives could raise the risk of venous thromboembolism (VTE) beyond that of other oral contraceptives following a preliminary review of several studies.
TRENTON, N.J. (AP) — Outside advisers to the Food and Drug Administration voted Thursday to recommend that the agency approve a new anticlotting drug for use in millions more patients.
- Page 1