Alvotech shares rose after the company said the Food and Drug Administration approved a new manufacturing process for Simlandi, its biosimilar to Humira. The stock was 8% higher, at $5.41, in morning ...

Even when AI designs molecules with potential as medicines, drug development can be delayed if the process of producing them ...

New draft guidance issued by the US Food and Drug Administration (FDA) is intended to clarify which changes to a pharmaceutical company's manufacturing process must be reported to federal regulators, ...

In advance of November 10, 2026 GDUFA goal date, three commercial lots of Preservative-Free Ketamine have been successfully ...

A single type of chemical structure that shows up again and again in modern medicine is the amide bond that links a carbonyl group (C=O) to a nitrogen atom. They're so ubiquitous that 117 of the top ...

A new Journal of Pharmaceutical Investigation special issue curated by three Korean guest editors will highlight ...

A proof-of-concept study has created a blueprint for producing prostate cancer treatment more efficiently. Researchers at the University of Missouri, Cancer Targeted Technology (CTT) and ...

As instigators of immunity, monoclonal antibodies are marvels of modern medicine, lab-made proteins that can treat cancers, autoimmune diseases, and many other conditions. With the market for these ...

Gilead Sciences got the ball rolling early on Yeztugo access, homing in on supply chain scale-up shortly after lenacapavir delivered impressive efficacy in HIV prevention trials in 2024. (Gilead ...

Future-ready pharma manufacturing requires flexible capacity, digital innovation, strong quality systems, integrated value ...

NRx Pharmaceuticals, Inc. announced completion of three Process Validation lots of preservative free Ketamine produced under commercial conditions in anticipation of the November 10 GDUFA Goal ...