The US Food and Drug Administration (FDA) approved or tentatively approved 776 Abbreviated New Drug Applications (ANDAs) for generic drugs in 2021, continuing a steady decline in generic approvals in ...

The US Food and Drug Administration (FDA) on Wednesday revised its questions and answers guidance on generic drug development and abbreviated new drug application (ANDA) submissions during the ...

At a time when many basic living expenses are rising, generic medicines play a critical role in expanding access to safe, ...

Guidance development and publication from the Food and Drug Administration (FDA) has long been considered an essential element of medical product development, approval, and regulation. While temporary ...

Patent expirations are increasingly concentrated in specialty, with >$43B in 2026 brand sales exposed and meaningful ...

Gottlieb is a senior fellow at the American Enterprise Institute and served as commissioner of the Food and Drug Administration from 2017 to 2019. President Trump often touted during his first term ...

The US Food and Drug Administration will take steps to streamline the development of generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to accelerate ...

Science, Technology, Regulatory Issues and Societal Dimensions in the Developing World” was inaugurated on Thursday at JSS ...

A new study finds that CivicaScript, a not-for-profit drug manufacturer in the US, can reliably supply essential generic medicines at a price that saves patients over 60%, and public and private ...

Forbes contributors publish independent expert analyses and insights. Sally Pipes is a scholar and think tank CEO who writes on health care. America’s generic drug market is one of our greatest health ...

The FDA approves Apotex Corp.'s plan to introduce generic Ozempic, a semaglutide injection that one study suggests could ...

Affordable, regulated versions of Ozempic, the well-known diabetes and weight-loss shot from Novo Nordisk, are about to hit markets around the world, which could shake up the obesity drug scene. The ...