The FDA PreCheck Pilot Program will focus on manufacturing readiness, regulatory predictability, and expedited facility ...
Ability to avoid pretransplant chemotherapy could open up stem cell transplants for patients who might otherwise be too sick ...
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.
A regulatory protein in astrocytes may explain how certain memories persist over time for learning and cognitive function.
Novartis has agreed to acquire Myricx Bio, a London-based developer of next-generation antibody-drug conjugates (ADCs), for ...
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 ...
To test this strategy, the team engineered protein immunogens that mimic key HIV envelope structures known to initiate bnAb ...
Under the two-year project timeline, researchers will spend the first year optimizing vaccine candidates and evaluating their ...
As genome editing therapies move through clinical trials to regulatory approval, scientists continue the quest for the holy ...
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.