Abbreviated New Drug Application

FDA
Manufacturing

FDA drafts new policies to boost US drug production

Amid the administration's tariff updates and drug pricing deal, the FDA made moves this week to incentivize drug manufacturing in the U.S.
Fraiser Kansteiner Oct 3, 2025 3:52pm
FDA clipboard

Regulatory tracker: Bayer adds new Kerendia CV outcomes nod

Aug 29, 2022 9:48am
FDA

3 months after pulling Pepaxto, Oncopeptides reverses stance

Jan 24, 2022 11:10am
Patheon part of Thermo Fisher Scientific

Thermo Fisher helps Civica Rx develop ANDAs to fight shortages

Jan 20, 2020 7:15am