For decades, the Food and Drug Administration has been notoriously tight-lipped about why it rejects drugs. It has remained ...

The FDA recently unveiled a new national priority voucher program that would seek to trade faster drug approvals for lower ...

GoodRx reports that in 2025, novel drug and biosimilar approvals lag slightly behind last year, while first generic approvals ...

Many companies face FDA complete response letters due to ongoing chemistry, manufacturing, and controls, or CMC, and ...

In a groundbreaking move, the FDA has approved a new UV light-based process for sanitizing raw milk — one that preserves its ...

A deep dive into the implications of the Replimune CRL that surprised insiders and investors, the role of new leadership at ...

Food and Drug Administration commissioner Marty Makary has chosen former biotech executive George Tidmarsh as the agency’s ...

Prefilled syringe eliminates the need to reconstitute separate vials prior to administration and simplifies the vaccine process.

Empower Pharmacy, a Houston-based compounding pharmacy, has been sanctioned by the FDA and other states in the past decade.

For instance, "the backlog of FOIAs ... is enormous," he said. Califf said the FDA has far greater opportunities for improved ...

The FDA has approved the natural color additive gardenia (genipin) blue for use in various foods and drinks at “levels ...

We need a dedicated framework that clarifies the rules, requirements and incentives for those building personalized ...