FDA aims to speed biosimilar approvals to increase competition, but experts warn drug prices may not drop quickly.

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.

Off-patent medicines provide people with access to high-quality essential treatment options that can be significantly less expensive than branded on-patent medicines. Off-patent therapies — generics ...

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 ...

Developing high-quality, safe, and effective drugs is a complex process that requires varied scientific skills and stringent regulatory assessments. Drug development is a process that spans many years ...

DUBLIN--(BUSINESS WIRE)--The "US Generic Drug Market: Industry Trends, Share, Size, Growth, Opportunity and Forecast 2023-2028" report has been added to ResearchAndMarkets.com's offering. The US ...

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 ...

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 ...

Generic drugs feature the exact same active ingredient, strength and dosing regimen as their brand-name predecessors, but, if it weren’t for their typically lower prices, they still wouldn’t be many ...

Christina Brown-Marshall Ph.D., Dexter Whitley Ph.D. Pharmaceutical patents have proven to be a highly effective incentive for groundbreaking innovation. However, corresponding drug prices have long ...