Early-stage regulatory strategy is becoming a powerful driver of speed, risk reduction, and commercial value in drug ...

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 ...

PharmTech spoke with Dr. Asma Patel, VP Global Commercial and Scientific Consulting–Drug Product, to find out how the growth ...

Moving a potential therapy from the laboratory to the pharmacy has always been a slow, incremental journey. “Drug development is a multi-stage process,” says Nichola McCann, associate principal ...

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.

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 ...

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 ...

VANCOUVER, British Columbia, July 14, 2025 (GLOBE NEWSWIRE) -- HYTN Innovations Inc. (HYTNF) (“HYTN” or the “Company”), a leader in pharmaceutical-grade cannabis manufacturing, is pleased to announce ...

The FDA designates ARB1002 as an orphan drug, highlighting its potential as a novel treatment for pancreatic cancer amid ...