GlycoEra’s lead candidate targets IgG4 autoantibodies, potentially addressing autoimmune diseases such as muscle-specific ...

According to President Trump, CMS Administrator Mehmet Oz is a “tough hombre” who can bring down drug costs “like a rock.” ...

Acute systemic infection caused the patient to develop fatal capillary leak syndrome, highlighting the unpredictability of ...

Prothena has already discontinued the development of birtamimab, and anticipates further spending cuts, including workforce ...

As the World Health Organization initiates a new agreement for coordinating global responses to future pandemics, the future of vaccine development in the U.S. faces growing challenges, including ...

The advisory committee meeting comes days after the FDA unveiled a new risk-based approval framework for COVID-19 vaccines.

While sparking excitement among biopharma companies focused on rare and ultrarare indications, experts say FDA Commissioner ...

The CMS last month declined to include anti-obesity medications in its Medicare coverage for Part D, a move that Lilly says ...

The approval tees GSK up to challenge Sanofi and Regeneron, which in September 2024 won the first biologic approval for COPD ...

The FDA had given Pfizer and Moderna until May 17 to propose changes to the labels of their COVID-19 vaccines or challenge ...

After discussions with the FDA, Moderna has withdrawn its application for a combination shot, which had demonstrated efficacy ...

In an opinion issued late Thursday night, U.S. District Judge Susan Illston wrote that the president and department agency ...