The U.S. regulator shared the roadmap for implementing the program, first proposed in August 2025, and teased changes made in response to industry feedback.

FDA authorizes compassionate use of urcosimod for neuropathic corneal pain, a condition that causes severe pain and ...

The FDA will begin accepting applications Feb. 1 for its PreCheck pilot program, an initiative designed to strengthen the domestic pharmaceutical supply chain. The program aims to increase regulatory ...

The company also stands to gain from recent regulatory FDA guidance aimed at streamlining the development of non-opioid ...

Big pharma is grappling with new drug pricing deals and roughly $300 billion in potential lost revenue from patent ...

Lexicon Pharmaceuticals, Inc. is downgraded to Hold due to repeated FDA rejections of ZYNQUISTA for T1D and catalysts. Read more on LXRX stock here.

The US Food and Drug Administration (FDA) has followed up on its promise to clampdown on misleading and deceptive drug advertisements in the US, with the agency publishing a large batch of warning ...

According to multiple recent market analyses, the global API market is experiencing steady growth. One comprehensive forecast projects the global active pharmaceutical ingredient market to expand from ...

Welcome to Fierce Pharma's regulatory tracker for the first half of 2026. On this page, we're recording the regulatory progress of in-market products, including expansions into key geographies and new ...

The Philippine Chamber of Pharmaceutical Industry expressed strong support for the Food and Drug Administration’s efforts to ...

THE Philippine Chamber of Pharmaceutical Industry (PCPI) has expressed strong support for the Food and Drug Administration’s ...