Several of the committee members asked at Thursday’s meeting about the FDA’s new vaccine approval framework. Some expressed ...

The FDA becomes involved before any new drug molecule is tested in humans. Here’s how upheaval at the agency appears to be affecting specific points in the approval process for new drugs.

Also called azodicarbonamide, the FDA previously approved ADA's use to whiten cereal ... Diamantas also said that details of the agency's systematic process to review the safety of chemicals ...

The Makary-Prasad leadership is likely to prompt several shifts in how companies design trials and navigate the FDA approval process: The biotechnology sector – from startup biotechs to large ...

"The FDA approval process is intended to assess safety and efficacy, and allow access to approved vaccines. It is not the place to make policy recommendations for how to use approved vaccines ...

Stroke survivors in Tulsa were invited to check out a new Food and Drug Administration (FDA) approved therapy aimed ... The therapy works through a process called Vagus Nerve Stimulation, which ...

FDA approval in December 2024 highlights the combination's efficacy, offering a primary treatment option for this aggressive cancer type. The regimen includes FOLFOX or FOLFIRI, with a 60% response ...

The Avmapki Fakzynja Co-Pack marks the first FDA-approved treatment for adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer who have received prior systemic therapy. The FDA has ...

MANILA, Philippines — The country’s regulator on food, drugs and cosmetics is looking to speed up its approval process ... Food and Drug Administration (FDA) Director General Samuel Zacate ...

RFK Jr. previously said he wants to phase out petroleum-based dyes. The U.S. Food and Drug Administration (FDA) approved on Friday additional color additives from natural sources in line with the ...

The combination of avutometinib and defactinib is the first FDA-approved treatment for KRAS-mutated recurrent LGSOC. Approval was based on the phase 2 RAMP-201 trial, showing a 44% overall ...

The U.S. Food & Drug Administration (FDA) has announced the approval of three natural-source colors in food items. Galdieria extract blue, butterfly pea flower extract and calcium phosphate can ...