Dr. Chandar Thakur, chief of the Medical Devices and Diagnostics Branch at DHA R&D-MRDC’s Office of Regulated Activities, is the 2024 Employee of the Year.

The FDA is expected to decide on treatments for COPD, psoriasis, rare neuroendocrine tumors, and a next-generation COVID-19 vaccine.

Massive cuts at the FDA have hit staff tied to drug reviews and user fees, putting future approvals in jeopardy, according to multiple reports.

The FDA has approved a new at-home test for common sexually transmitted infections and diseases. The test for chlamydia, ...

Trump cutbacks were supposedly aimed at administrators. But scientists in food and drug-testing labs and policy experts who ...

The Food and Drug Administration (FDA) has granted accelerated approval to Vanrafia ® (atrasentan) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid ...

Eli Lilly (LLY) leads with groundbreaking tirzepatide (Mounjaro/Zepbound), while Hims & Hers Health (HIMS) faces challenges.

Amid a raft of federal changes cutting funding and capacities at the Food and Drug Administration, investors are soon ...

The recent uptick and rise in popularity of GLP-1 drugs for addressing weight loss and obesity has led to an increase in U.S. litigation ...

This article examines post-market drug safety, highlighting surveillance mechanisms, regulatory responses, and case studies of approved drugs with hidden risks.

President Trump yesterday announced a baseline tariff of 10% on all imported products and higher rates on certain countries ...

Co-production deals with adalimumab biosimilar manufacturers and PBMs have increased biosimilar adoption, but this ...