In a university lab, an AI system generated millions of novel molecules to fight drug-resistant infections. And they're ...

Following Afghan shooting case, Trump administration launches rigorous audit of immigration status for residents from nations ...

The next critical steps in the USFDA process involve a rigorous on-site evaluation: "visiting manufacturing facilities, ...

(hereinafter referred to as “Juventas”) announced that its independently developed CAR-T cell therapy product, Inaticabtagene Autoleucel (Ina-cel) (tradename: YORWIDATM), has received new drug ...

Powerful” new treatments for various types of cancer and neurodegenerative disorders, such as Alzheimer’s, Parkinson’s, and ...

In this Q&A, John Kirk, principal regulatory specialist at Veristat, explains how the FDA’s Commissioner’s National Priority ...

The Food and Drug Administration (FDA) has issued a statement, published electronically in the New England Journal of ...

The U.S. Food and Drug Administration (FDA) has granted fast track designation to DPTX3186, a first in class oral condensate ...

Two members of Congress launched an investigation into FDA Commissioner Marty Makary, MD, MPH, and his use of " priority vouchers " for expedited drug approvals, suggesting that the voucher program ...

Companies should really sit down and say, could I meet these points?” Hogan Lovells partner Lynn Mehler said. “How do I ...

Khorakiwala said the Mumbai-based drugmaker is already laying groundwork for commercialization, with options ranging from ...

The hospital lobby has filed a lawsuit seeking to block the federal government’s 340B Rebate Model Pilot Program, which is ...