After raising nearly $90 million in its recent public offering, Vancouver-based Absci is advancing toward clinical trials for what would be its first biologic drug candidate. Absci uses its database ...

The Food and Drug Administration (FDA) is launching an effort to streamline the approval process for cheaper alternative “biosimilar” versions of biologic drugs as a way to curb health costs. The ...

The US Food and Drug Administration will take steps to streamline the development of generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to accelerate ...

The Food and Drug Administration said it will be taking steps to speed up the approval process for developing generic biological drugs, an effort aimed at increasing cheaper competition among ...

Biologic drugs, made from living organisms and usually taken by injection or infusion, are expensive treatments for complex chronic conditions such as cancer and autoimmune diseases. Biosimilars, ...

Opinions expressed by Digital Journal contributors are their own. Bringing a new biologic drug from concept to clinic is a complex journey fraught with technical and regulatory hurdles. For ...

Formulation development serves as a vital bridge between a drug substance and a drug product that will remain stable and ...

TORONTO and HAIFA, Israel, Feb. 02, 2024 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (NRX:CA) (FSE: J90) (NRX.V), known as "NurExone," is pleased to announce the initiation of the Orphan Drug ...

Drug Substance manufacturing is a critical component of pharmaceutical production, requiring precise processes, rigorous quality control, and innovative solutions to overcome various challenges. From ...

WASHINGTON - The Food and Drug Administration announced Wednesday that it plans to streamline the approval process for cheaper, "biosimilar" alternatives to biologic drugs in an effort to reduce ...