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 ...

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 ...

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.

With each new year comes a new set of accompanying challenges, from tackling the latest innovations to new incarnations of old issues. 2025 will be no exception to this rule, and with its arrival we ...

Study breaks down high U.S. drug pricing. — -- High prescription drug prices in the United States are largely due to drug monopolies and restrictions on price negotiations, according to a new ...

Indian pharmaceutical companies are gaining ground in the Chinese market, winning bids to supply bulk generic drugs, including Dapagliflozin for diabetes treatment. Hetero Labs Limited, Cipla Ltd, ...