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.
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.
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.
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...