March 11 (Reuters) - The U.S. Food and Drug Administration said on Wednesday it has introduced a unified platform designed to ...

Makary pointed to three bottlenecks: hospital contracting; ethical reviews and approvals; and the Investigational New Drug applications process ...

COPENHAGEN, March 10 (Reuters) - Novo Nordisk said on Tuesday it had received a warning letter from the U.S. Food and Drug ...

The FDA issued a warning letter to Novo Nordisk, the Danish drugmaker behind the diabetes and weight-loss medications Ozempic and Wegovy, over unreported potential side effects.

In another development, 25 states have petitioned to join a lawsuit and defend the EPA’s decision to rescind the climate endangerment finding ...

WASHINGTON, Feb 1 (Reuters) - The U.S. Food and Drug Administration on Sunday began accepting requests to participate in its PreCheck pilot program, designed to boost domestic drug supply by speeding ...

March 13 (Reuters) - British drugmaker GSK said on Friday the U.S. Food and Drug Administration has expanded the approved age range for its respiratory syncytial virus vaccine, Arexvy, to include ...

Add Yahoo as a preferred source to see more of our stories on Google. FILE PHOTO: FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S ...

WASHINGTON — Sen. Josh Hawley rolled out long-shot legislation this week to override the Food and Drug Administration’s approval of mifepristone, part of a two-drug regimen responsible for the ...

Amid an outpouring of industry investments in U.S. drug production, the FDA has launched a new program designed to significantly reduce the complexities involved in setting up domestic manufacturing ...