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, ...

Vivex Biologics chairman John McCallum breaks down the challenges, costs, and strategies behind bringing medical innovations ...

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 ...