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 ...

WASHINGTON (CBS.MW) -- The U.S. Food and Drug Administration issued guidelines Wednesday clarifying the process for making changes to a generic drug application. The document also covers other generic ...

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 ...

Global & regional market size forecasts through 2035. Competitive benchmarking and SWOT analysis of top providers. Segmentation insights. Regulatory and sustainability landscape ...

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 ...

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 ...

Brand-name medications go through extensive clinical trials to show the safety and efficacy of treatment to receive Food and Drug Administration (FDA) approval. Once FDA-approved, the brand ...

In October 2021, we reported on an uptick in the passage of state drug price transparency legislation. As an update to that report, as of October 2023, approximately 22 states have now passed drug ...