A new effort called Operation Stork Speed aims to fix outdated FDA rules that block alternative baby formulas from reaching U ...

The US Food and Drug Administration’s new standards for foods before they can be labeled as “healthy” on their packaging will go into effect about two months later than planned, according to ...

A Texas court has struck down the FDA’s Final Rule to regulate LDTs in the same way as medical devices. But is that the end of the story?

Business New FDA rules for TV drug ads: Simpler language and no distractions The new rules, which cover both TV and radio, instruct drugmakers to use simple, consumer-friendly language when ...

A Delaware federal judge has ruled that Novartis cannot prevent MSN Pharmaceuticals from introducing a generic version of its ...

The agency disclosed a tranche of more than 200 complete response letters from the past five years, but only those involving ...

Oncologists were one of the few provider groups to register support for the FDA rule, reflecting the challenge of assessing ...

Former Escambia County deputy Augustus Fetterhoff pulled into a person's backyard and searched their vehicle without a ...

FDA approved label changes for Breyanzi and Abecma, easing access by reducing monitoring rules and eliminating REMS safety program requirements.

Biocryst is offloading part of its business for $250 million. Meanwhile, the former FDA leader took issue with a new policy ...

The drug gained a following in some circles for its supposed ability to treat COVID-19 safely, something all major medical ...

The U.S. Food and Drug Administration (FDA) announced on June 18, 2025, the release of its proposed method for ranking ...