The U.S. Food and Drug Administration (FDA) on Dec. 2, 2025, issued its draft guidance on Monoclonal Antibodies: Streamlined Nonclinical Safety Studies Guidance for Industry, the agency's most recent ...
As regulatory authorities accelerate the use of New Approach Methodologies (NAMs), the drug discovery landscape is changing dramatically. This webinar explores how NAMs, immunology-driven platforms, ...
Add Yahoo as a preferred source to see more of our stories on Google. This story was originally published on PharmaVoice. To receive daily news and insights, subscribe to our free daily PharmaVoice ...
DiNABIOS Applauds Historic U.S. Senate Passage of FDA Modernization Act 3.0, Advancing Human‑Relevant New Approach Methodologies (NAMs) ZURICH/SCHLIEREN, Switzerland, December 24, 2025 – DiNABIOS AG, ...
On February 2, 2026, FDA’s new Quality Management System Regulation (“QMSR”) for medical devices became effective, two years after FDA’s issuance of a final rule to implement the QMSR. The QMSR ...
RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Simulations Plus, Inc. (Nasdaq: SLP) (“Simulations Plus” or the “Company”), a global leader in model-informed and AI-accelerated drug development that ...
This article is the latest in the Health Affairs Forefront featured topic, “Health Policy at a Crossroads,” produced with the support of the Commonwealth Fund and the Robert Wood Johnson Foundation.
Some results have been hidden because they may be inaccessible to you
Show inaccessible results