The FDAAA did not significantly alter the overall time to first postmarket safety action for novel therapeutics. Earlier safety actions were observed within the first five years post-approval, ...

The Food and Drug Administration is a government agency that regulates certain food, drugs, cosmetics, and medical products.

Generic drugs account for more than 90 percent of prescriptions filled in the United States. Recent studies have found concering variability in quality and safety America’s generic drug supply, most ...

Most of the oncology drugs that received the FDA’s accelerated approval from 2011 to 2020 had some kind of FDA postmarketing safety action, according to a research letter. Safety actions included ...

No new signals for lecanemab emerged in ALZ-NET ...

ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive our biggest stories as soon as they’re published. The dispatches from one of India’s most troubled generic drug ...

Although Sarepta Therapeutics managed to defuse a brief stalemate with the FDA earlier this week, the U.S. drug regulator is reportedly going to put the company to work in order to affirm the safety ...

Founded by Flagship Pioneering in 2019, Cellarity seeks to embrace biology’s complexity, as diseases are often not driven by a single target, but emerge from a cascade of cellular interactions that ...

The evaluation of drug safety in clinical trials is a critical element of the drug development process, ensuring that therapeutic benefits outweigh potential harms. Clinical trials, particularly in ...

Prescription and over-the-counter (OTC) medications play vital roles in treating health conditions for older adults, helping ease symptoms and supporting overall well-being. To ensure the intended ...

The sounds of muffled percussion and audience cheers reverberate throughout the grounds. Brand activations, makeshift bars and restaurant pop-ups control traffic as a sea of bodies move from set to ...