Lower middle- and low-income countries are less likely to receive market authorization for drugs that were trialed within their state and approved by the FDA within 5 years of approval when compared ...

In letters to the US Food and Drug Administration (part of the HHS) and the USDA’s Food and Nutrition Service (FNS), the two ...

Poherdy is the first FDA-approved interchangeable biosimilar to Perjeta for HER2-positive breast cancer, potentially expanding access and reducing costs. Approved for use in combination with ...

Private certification, insurer evaluation and peer-reviewed research step up.

The FDA's push for lower-cost medicines looks good on paper, but the patent office under President Trump may be going in the ...

The FDA has approved a biosimilar of pertuzumab which is indicated for multiple breast cancer settings. The FDA has approved ...

The new federal funding law fully restores operations at FDA and USDA through September 30, 2026, and includes food safety ...

Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts ...

WASHINGTON — Food industry coalitions the Grain Chain and the Food & Beverage Issue Alliance (FBIA) have urged the US Department of Health and Human Services (HHS) and the US Department of Agriculture ...

Drugs approved by the FDA’s expanding program to expedite reviews for products in line with the Trump administration’s agenda ...

The appointment of Pazdur as CDER head comes shortly after the surprise ousting of George Tidmarsh and should quiet many of ...

The FDA has approved Caplyta as adjunctive therapy with antidepressants to treat major depressive disorder in adults, ...