The US Food and Drug Administration (FDA) has published a manual of policies and procedures (MAPP) outlining how the Office of Generic Drugs (OGD) will classify which new drugs and drug-device ...

Federal regulators have agreed to review a Swiss pharmaceutical company's applications for two cheaper generic versions of ...

Delve into the hidden innovation system of drug repurposing. When patents expire and commercial value fades, a new wave of ...

Designing an efficient platform is crucial for any industrial process. This design process is known as process development, and it has become increasingly important in the pharmaceutical industry at ...

This Brush Up is sponsored by MilliporeSigma. Learn more about therapeutic synthesis pathways. Drug development is a process that spans many years, from the initial phase of identifying potential drug ...

AI is increasingly used to accelerate and improve drug discovery and development. AI tools, like AlphaFold and autonomous labs, help identify targets and process massive datasets. Regulatory standards ...

AAM said the law sets up a process under which a drug would have price controls applied before a generic or biosimilar even had the chance to come to market. AAM sends letters to House on HR 987 AAM, ...

A generic version of Wegovy is not currently available in the United States due to patents held by the manufacturer, Novo Nordisk, that may remain in effect until 2041. When the U.S. patent for ...

Ed Silverman formerly piloted The Wall Street Journal's Pharmalot blog tracking the pharmaceutical industry. His coverage included research and development, marketing, pricing, regulation, deals, ...