SK pharmteco today announced the successful conclusion of a regulatory inspection of its small molecule North America facility in La Porte, Texas. The U.S. Food and Drug Administration (FDA) carried ...

Simtra BioPharma Solutions was issued a warning letter by the FDA after an inspection uncovered a number of problems at the ...

Previously, the Company had received CRLs in November 2023 and April 2025 due to insufficient evidence in addressing the ...

Industry and FDA representatives have reached a general agreement on planned pre-submission facility meetings but have expressed different views about the specifics.

The FDA PreCheck program, first announced in August, aims to streamline review of domestic pharmaceutical plants and eliminate unnecessary ‌regulatory requirements, in line with ⁠President Donald ...

Add Yahoo as a preferred source to see more of our stories on Google. A U.S. flag, a U.S. Food and Drug Administration (FDA) logo, a syringe and a vial are seen in this illustration taken May 13, 2025 ...

FDA replaces seven fragmented adverse event databases with AEMS, enabling real-time safety signal access for pharmaceutical manufacturers and researchers. On March 11, the FDA launched a unified ...

Novo Nordisk's reports to the FDA spiked shortly after an inspection found the Ozempic producer ignored reports of deaths and ...

Since 2000, pharmaceutical manufacturing has increasingly moved offshore. Today, approximately 53% of brand drug products and 69% of generics have at least one manufacturer outside the United States.

The Trump administration recently celebrated one year of embracing the movement to Make America Healthy Again. Unfortunately, ...

Makary said the FDA is looking at prescription drugs like nausea medications and vaginal estrogen, and hopes to make changes ...

The FDA began accepting requests Feb. 1 to participate in its PreCheck pilot program, an initiative aimed at streamlining regulatory review for new U.S.-based pharmaceutical manufacturing facilities.