Category: New Drug

TUESDAY, Dec. 19, 2017 (HealthDay News) -- The U.S. Food and Drug Administration on Tuesday called for tougher warnings and "additional research" into a dye commonly used with standard MRIs.

The dye -- a "contrast agent" -- contains a metal called gadolinium. It made news recently after claims from actor Chuck Norris that its use...

Of the more than 200 drugs cleared by the FDA between 2001 and 2010, nearly one-third exhibited safety risks that were only identified after their approval, according to a new study published in JAMA.

To be clear, most of the concerns were not severe enough for a recall (only three drugs were...

Drugmaker Mylan NV failed to investigate why medications made at a factory in India didn’t meet quality standards and frequently didn’t report the substandard results from its tests, the U.S. drug regulator said.

The quality system at Mylan’s facility in Maharashtra, India, “does not adequately ensure the accuracy and integrity of data...

The FDA has issued a safety announcement warning that Viberzi should not be used in patients who do not have a gallbladder due to an increased risk for serious pancreatitis.

Hospitalizations and deaths due to pancreatitis have been reported with the use of this drug in such patients, with symptom onset occurring with just one...

Juno Therapeutics Inc on Wednesday said it decided to shut down development of an experimental leukemia treatment from a highly promising new class of immunotherapy following an investigation into toxicity that led to a handful of patient deaths.

The drug, JCAR015, uses a technology known as CAR-T being pursued by other companies as well. CAR-T...

Studies drug companies fund after medicines go on sale may be too small to detect rare side effects, a recent German study suggests.

Even if these so-called post-marketing studies do uncover previously undetected adverse events, physicians conducting the trials are often required to keep results confidential, limiting the potential for regulators or patients...

Nearly 5 million Medicare prescription drug enrollees aren't taking their blood pressure medication as directed, increasing their risk of heart attack and stroke, a new U.S. study found. An analysis of 18.5 million Medicare Part D enrollees in 2014 found that 26 percent either skipped doses of their blood pressure medication or stopped taking the...

A steep increase in the price of the EpiPen, a lifesaving injection device for people with severe allergies, has sparked outrage among consumers and lawmakers who worry that parents won’t be able to afford the pens for children heading back to school.

With a quick stab to the thigh, the EpiPen dispenses epinephrine, a drug...

For college students and late night workers, consuming caffeine and energy drinks is often the only way to concentrate when exhausted. But drinking too many energy drinks — like Red Bull, Monster, Amp, or Burn — can be dangerous to your health, especially for your heart. A new case study published in the Journal of...

The Food and Drug Administration said Wednesday that it had approved generic versions of the blockbuster cholesterol-lowering pill Crestor, rejecting a last-ditch and controversial effort by AstraZeneca to stop cheaper competition from reaching pharmacy shelves.

The move should considerably decrease the price of the...