The API is, one might say, the most important element in a pharmaceutical product. Poor-quality APIs that do not meet potency ...

Because price and margin headwinds exist predominantly in small-molecule oral tablets that are easy to produce, we expect Viatris’ future pipeline to focus more on complex generics—drugs that have ...

The U.S. Food and Drug Administration (FDA) on Thursday announced an expedited plan to implement artificial intelligence (AI) ...

Explore how LC-MS technologies are transforming forensic and clinical toxicology by enabling comprehensive compound detection ...

FDA Commissioner Marty Makary’s proposal to roll out a new drug approval pathway is heightening hope for the rare disease ...

U.S. pharmaceutical companies are increasingly licensing new drugs from China. Former FDA Commissioner Scott Gottlieb ...

Qualification program creates a pathway to evaluate Clinical Outcome Assessments (COAs) that capture a specific concept of interest (COI) in a specified Context of Use (COU). If successfully qualified ...

The plans amount to an extraordinary flex of Robert F. Kennedy Jr.’s power as health secretary to make decisions ordinarily ...

AHA comments on the Centers for Medicare & Medicaid Services information collection request regarding the Medicare Transaction Facilitator (MTF) under the Medicare drug negotiation program.

Drug approval is unequivocally the linchpin to any drug development effort and, given the role of the US market in the global ...