WASHINGTON - The Food and Drug Administration announced Wednesday that it plans to streamline the approval process for cheaper, "biosimilar" alternatives to biologic drugs in an effort to reduce ...

In a promising move to tackle the escalating costs of prescription drugs, a new initiative known as the Limited-Competition Generic Market Priority Review Voucher (LCGM PRV) Program is making waves.

Drug development pipelines are the lifeblood of the pharmaceutical industry. It is crucial for investors to understand milestones like FDA approvals and the impact of losing exclusivity on profits to ...

Attempts to curtail the cost of pharmaceuticals by both political parties have drastically increased as millions of Americans are unable to fill their prescriptions due to cost, leading to lapses in ...

It's the Trump administration's latest move to rein in high prescription drug costs in the U.S., and could be a blow to pharmaceutical companies.

U.S. regulators approved dozens of inhalers to treat asthma and chronic obstructive pulmonary disease over a recent 15-year period, but a new study found that generic companies have only twice ...

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 ...

The United States has said it will speed up approval for some generic drugs. The development comes weeks after it was reported that the Trump administration had dropped its plans to impose tariffs on ...