Veteran radiopharmaceutical executive joins to accelerate partnerships, regulatory alignment, and scalable growth in ...

The U.S. Food and Drug Administration issued its first formal guidance on how to design and run clinical trials for ...

InstantGMP Named #1 for EBR, LIMS & MES Integration Being recognized by Root Analysis as the number one provider of ...

The Food and Drug Administration's about-face comes a little more than a week after the agency refused to consider the ...

Explore FDA's QMSR and cybersecurity mandates for medical devices, including SPDF, SBOMs, and legacy medical device ...

The USFDA further highlighted deficiencies in environmental monitoring in manufacturing areas, indicating gaps in ensuring controlled production conditions.

What’s been overlooked is that the FDA already has the power to fix this. Without new legislation, pilot programs, or years ...

The USFDA completed a Pre-Approval Inspection at Enzene Biosciences, Alkem Laboratories’ subsidiary in Chakan, Pune, on 13th ...

Alkem Laboratories on Monday said the US health regulator has issued a Form 483 with six observations after inspecting the Chakan-based manufacturing unit of its wholly-owned subsidiary.

Black Mesa announces funding from the Advanced Research Projects Agency for Health (ARPA-H) to develop a Good AI ...

Solid Biosciences Inc. is a Strong Buy driven by positive FDA alignment on phase 3 IMPACT DUCHENNE trial for SGT-003. Read ...

Shares of Pharming Group fell after the Food and Drug Administration requested more information from the company on Joenja, its candidate to treat a rare immunodeficiency in children. Shares were down ...