The FDA PreCheck Pilot Program will focus on manufacturing readiness, regulatory predictability, and expedited facility ...

New perfusion technologies and AI-driven controls are accelerating adoption across commercial biologics manufacturing.

USP’s Diane McCarthy on the emerging standards platform and opportunities for stakeholders to help shape standards evolution.

Ability to avoid pretransplant chemotherapy could open up stem cell transplants for patients who might otherwise be too sick ...

Novartis has agreed to acquire Myricx Bio, a London-based developer of next-generation antibody-drug conjugates (ADCs), for ...

A regulatory protein in astrocytes may explain how certain memories persist over time for learning and cognitive function.

Fast, local cryopreservation is a consistent bottleneck for autologous cell therapy developers, even in major cell and gene therapy hubs.

Vertex Pharmaceuticals has agreed to acquire Crinetics Pharmaceuticals for $10 billion cash, in a deal that would expand the ...

Under the two-year project timeline, researchers will spend the first year optimizing vaccine candidates and evaluating their ...

By restoring the body’s ability to produce KLK1, therapies are emerging for preeclampsia moms and for acute ischemic stroke who missed the tPA window.

As genome editing therapies move through clinical trials to regulatory approval, scientists continue the quest for the holy ...

Researchers have developed new AI approach to select chemical compounds potentially effective for treating tuburculosis.