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 ...

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 U.S. Food and Drug Administration will take steps to streamline the process to develop generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to ...

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 ...

While humanized animal models are relatively new to drug development compared to their non-humanized counterparts, they are critical tools in the landscape of biologic drug development. Their success ...

Once the active ingredient is defined, an Applicant must select which patent, or patents, to put forward for extension. The statute permits only one PTE per regulatory review period, so the choice is ...

Health and Human Services Secretary Robert F. Kennedy Jr. unveiled a new plan on Wednesday that he said will drastically reduce drug prices in the U.S. He said the U.S. Food and Drug Administration is ...

The Biologics Price Competition and Innovation Act of (BPCI Act) of 2009 granted responsibility to the FDA for review and approval of a new class of pharmaceuticals referred to as “Biosimilars.” (1) ...

Forget the drug discovery hype. Here’s how the world’s largest pharma company is seeing a payoff from AI right now.

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 ...

Dublin, Feb. 17, 2026 (GLOBE NEWSWIRE) -- The "Pharmaceutical Manufacturing Market - Global Forecast 2026-2032" report has been added to ResearchAndMarkets.com's offering. The pharmaceutical ...