Biphenomycins, natural products derived from bacteria, show excellent antimicrobial activity, but have long remained out of reach for drug development. The main obstacle was the limited understanding ...

On Dec. 6, 2024, the FDA released draft guidance, marking a significant development in the regulatory framework for therapies approved under the Accelerated Approval Program. The 22-page guidance ...

The FDA Modernization Act of 1997 established the Fast Track designation to expedite developing and reviewing new drugs designed to fill unmet medical needs and treat serious conditions. The FDA Fast ...

The US Food and Drug Administration (FDA) has created a new pathway to streamline rare disease drugs through regulatory approval, allowing pharma companies to lean on smaller amounts of clinical data.

RESEARCH TRIANGLE PARK, N.C., Dec. 04, 2025 (GLOBE NEWSWIRE) -- Merakris Therapeutics, a clinical-stage biopharmaceutical company focused on advancing innovative biologic drug therapies for chronic ...

Bissan Al-Lazikani (left) is a Professor of Genomic Medicine and Director of Therapeutics Data Science at The University of Texas MD Anderson Cancer Center (Houston, TX, USA), where she heads an ...

Designing an efficient platform is crucial for any industrial process. This design process is known as process development, and it has become increasingly important in the pharmaceutical industry at ...