Global harmonization of CMC guidelines is a key focus for top pharmaceutical consultants. Variations in regulatory requirements across regions often create inefficiencies in drug development—for ...

When pharmaceutical companies develop a novel drug for the market, several steps are required to assess and regulate its safety, effectiveness, manufacturability, and reliability. These processes, and ...

SHELTON, CONNECTICUT / ACCESS Newswire / February 10, 2026 / NanoViricides, Inc., a publicly traded company (NYSE ...

There has been much discussion recently about how artificial intelligence and machine learning (AI/ML) will revolutionize pharmaceutical research. Substantial progress has been made in the discovery ...

ADCs combine antibodies with drug payloads for targeted therapy, but complex manufacturing requires monitoring CQAs across multiple entities.

US Food and Drug Administration, Silver Spring, MD, USA. Amyotrophic lateral sclerosis (ALS) is a severe progressive, neurodegenerative disease. It is also rare, and has been the focus of substantial ...

This investment comes as LGM Pharma experiences sustained growth in prescription drug projects, including 505(b)(2) and Abbreviated New Drug Application (ANDA) programs. The Rosenberg facility ...

Investor enthusiasm and evolving FDA pathways are accelerating rare disease drug development, with ultrarare conditions like ...

—The Noramco Group Addresses Critical Supply Chain Challenges, Offering Comprehensive Active Pharmaceutical Ingredients (API) and Drug Product Solutions— WILMINGTON, Del.--(BUSINESS WIRE)--Noramco, a ...

A drug selected for the latest round of Medicare drug price negotiations stands to get dropped because a lower-cost ...