On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for ...
Changes to the FDA labeling guidance in support of FALCPA include alterations to the definitions of “major” food allergens ...
The FDA has approved Evrysdi in tablet form for patients with spinal muscular atrophy aged 2 years and older who weigh more ...
FDA published a final version of its guidance document, “Communications From Firms to Health Care Providers Regarding ...
On January 7, 2025, the U.S. Food and Drug Administration (“FDA”) issued draft guidance, titled “Artificial ...
Gottlieb, who led the agency during the first Trump presidency, supports a reversion to an earlier interpretation of the 21st ...
While a pause on federal health agencies is nothing new during presidential transitions, the Trump Administration’s ...
While the continued erosion of Biogen’s multiple sclerosis franchise and weaker-than-expected 2025 guidance doesn’t seem to ...