As global health threats continue to evolve rapidly, pharmaceutical leaders face mounting pressure to design development programs that can withstand volatility. From pandemics to geopolitical unrest ...
FDA Commissioner Marty Makary, M.D., M.P.H., characterized the program as a “bold step” to bring manufacturing back to the US and make the domestic sector more resilient and competitive. This program ...
On February 1, FDA announced a new pilot program designed to promote the construction of domestic manufacturing sites, along ...
In February 2025, the Office of Inspector General (OIG) for the US Department of Health and Human Services issued favorable advisory opinions Advisory Opinion 24-10 and Advisory Opinion 24-12, ...
The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-11 (the “Opinion”), to a pharmaceutical ...
Approximately 70 million people that live, work or vacation in areas of the U.S. in which Lyme disease is endemic could potentially benefit from pre-exposure prophylaxis TNX-4800 was studied in a ...
TORONTO--(BUSINESS WIRE)--Conscience, a non-profit focused on accelerating drug discovery in areas of unmet medical need using open science and radical collaboration, is pleased to announce three ...
The 340B Drug Pricing Program was originally constructed so safety-net health care facilities could stretch scarce resources in caring for low-income patients. However, the program has experienced ...
RESEARCH TRIANGLE PARK, N.C., March 6, 2025 /PRNewswire/ -- Bantam Pharmaceutical, a drug discovery and development company targeting selective modulation of mitochondrial dynamics in cancer, today ...
Exploring clinical development plan options including a controlled human infection model (CHIM) and a Phase 2/3 adaptive field study Expect to have investigational product of TNX-4800 (anti-Borrelia ...