Stability testing is essential in the pharmaceutical and biopharmaceutical industries. These tests are performed to evaluate the stability of drug products under various environmental conditions. Once ...

A new study uses accelerated aging as a method to reduce the duration of studies examining the stability of DNA in forensically relevant biological samples on swabs. A new study from researchers at ...

Advanced kinetic modeling (AKM) can accurately describe the complex behaviors of biologics, reducing risks from the developmental stage all the way through last-mile delivery. Importantly, regulators ...

The Food and Drug Administration’s Dr. Robert Califf called on insurers Thursday to help ensure that studies on new drugs in the accelerated approval pathway are still completed. “I don’t think it’s ...

The U.S. Food and Drug Administration’s accelerated approval program is meant to give patients early access to promising drugs. But how often do these drugs actually improve or extend patients’ lives?

Doctors told Kristi Alcayaga it was time to bring out the "big gun" to fight her teenage son's leukemia. She expected the chemotherapy he was prescribed to be blue. Or red. Or some sinister color to ...

A special Food and Drug Administration process to get patients earlier access to new drugs has come under fire. The accelerated approval process speeds medicines to market based on preliminary study ...