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Results for search "Drug Approvals".

Health News Results - 17

An outside advisor to the U.S. Food and Drug Administration's review of the controversial Alzheimer's drug Aduhelm is now speaking out, arguing that the approval was based on dodgy science and involved questionable collaboration between regulators and the drug's maker.

"I'm not surprised at the controversy because I think it's a horrible decision. I think the FDA got it wrong," said Dr. G...

The controversial new Alzheimer's drug Aduhelm is creating something of a civil war in medicine, as health networks, hospitals, insurers and individual doctors weigh impending discussions with patients about whether they should take the medication.

Many doctors believe the U.S. Food and Drug Administration "moved the goalposts" to approve Aduhelm (aducanumab) in early June, and they aren'...

The first full approval of a drug to treat lymphoma in dogs has been granted by the U.S. Food and Drug Administration.

"While canine lymphoma affects fewer than 70,000 dogs in the U.S. annually, it accounts for up to 24% of all cancers in dogs, making it one of the most significant canine cancers," Steven Solomon, director of the FDA's Center for Veterinary Medicine, said in an agency new...

The U.S. Food and Drug Administration has approved the first new drug to treat Alzheimer's disease in nearly two decades, in a controversial decision that left the agency defending its reputation and its science.

Aduhelm (aducanumab) treats Alzheimer's by clearing out amyloid beta, a sticky protein known to form plaques in the brains of early-stage patients.

It is the first approved...

The first drug ever shown to slow the progression of Alzheimer's disease could be approved by the U.S. Food and Drug Administration on Monday, but experts say that approval will be surrounded by controversy.

In clinical trials, aducanumab showed a 22% reduction in the development of thinking and memory problems associated with Alzheimer's disease, according to a statement from the Alzheim...

Like many proud moms, Lisa Stockman-Mauriello of Summit, N.J., is looking forward to exciting milestones in lives of her three sons over the coming months: One will graduate college, one will enter college, and the third will begin high school.

But unlike other moms, it's not guaranteed that she'll be there to experience them.

Lisa, 51, has amyotrophic lateral sclerosis (ALS), a di...

The first monthly shots to treat adults with HIV were approved by the U.S. Food and Drug Administration on Thursday.

"Currently, the standard of care for patients with HIV includes patients taking daily pills to adequately manage their condition. This approval will allow some patients the option of receiving once-monthly injections in lieu of a daily oral treatment regimen," said Dr. John...

A newly approved drug for the leading form of the number one cancer killer, lung cancer, does improve patient survival, a new study confirms.

The immunotherapy drug Tecentriq (atezolizumab) was approved earlier this year by the U.S. Food and Drug Administration to treat patients with newly diagnosed non-small cell lung cancers (NSCLC), which comprise up to 85% of all lung tumors.<...

The first generic version of Daraprim (pyrimethamine) tablets for the treatment of toxoplasmosis has been approved by the U.S. Food and Drug Administration.

"Today's approval is especially important for populations that are more susceptible to toxoplasmosis infections, such as pregnant women and individuals with HIV or AIDS, by paving the way for more choices in treatment options," FD...

New drugs are being approved by the U.S. Food and Drug Administration for patients based on less and less solid evidence, thanks to incentive programs that have been created to promote drug development, a new study shows.

Researchers report that more than 8 out of 10 new drugs in 2018 benefitted from at least one special program that streamlines the approval process.

The res...

The first Ebola vaccine approved by the U.S. Food and Drug Administration is a single-dose injection called Ervebo.

The vaccine from Merck & Co. is approved to protect against the Zaire ebolavirus in people 18 and older.

In the United States, Ebola infections are rare. Confirmed cases have involved people in other countries who became infected and then traveled to...

The first generic versions of the multiple sclerosis drug Gilenya have been approved by the U.S. Food and Drug Administration.

The three generic versions of Gilenya (fingolimod) capsules were approved for the treatment of relapsing forms of multiple sclerosis (MS) in adults.

"Approving safe and effective generics so patients have more treatment options continues to be a prio...

A new drug has been approved as part of a powerful, three-pronged treatment regimen for the most deadly strain of tuberculosis, the U.S. Food and Drug Administration announced Wednesday.

Pretomanid tablets were approved to be used with bedaquiline and linezolid in adults with extensive multidrug-resistant tuberculosis (XDR-TB) of the lungs. Caused by a bacterium that attacks the lung...

The U.S. Food and Drug Administration has approved another new multiple sclerosis drug -- the second in one week.

Mavenclad (cladribine) pills can be used to treat relapsing forms of MS in adults, including relapsing-remitting disease and active secondary progressive disease. The drug is not recommended for MS patients with a course of the disease known as clinically isolated syndrome...

The U.S. Food and Drug Administration on Tuesday approved a new generic version of the high blood pressure/heart failure drug valsartan, saying the move might help ease the current medication shortage.

The agency said it prioritized review of the drug from Alkem Laboratories Ltd. after multiple recalls of other generic valsartan products depleted supplies.

Those recalls occ...

Easing chronic pain is the main reason Americans use medical marijuana, a new study finds.

"We wanted to understand the reasons why people are using cannabis medically, and whether those reasons for use are evidence-based," said lead author Kevin Boehnke. He's an investigator at University of Michigan's Chronic Pain and Fatigue Research Center.

Boehnke and his colleagues exa...

The first generic version of the widely used Advair Diskus inhaler for asthma and chronic obstructive pulmonary disease (COPD) has won U.S. Food and Drug Administration approval.

This approval "is part of our longstanding commitment to advance access to lower cost, high-quality generic alternatives," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Researc...