JD Supra8d
Rethinking FDA’s Accelerated Approval Pathway: New Draft Guidances and Implications for Drug Companies
The U.S. Food and Drug Administration (FDA) recently issued two new guidance documents governing details of the Accelerated Approval ...
pharmaphorum9d
Innovative Regulatory Pathways Summit
Innovative Regulatory Pathways Summit will bring together leading ... to increase communication and collaboration with the FDA, to enable efficient drug development. Accelerated drug development ...
Pharm Exec10d
Challenges to Navigating the Pharmaceutical Regulatory Landscape
In the United States, the biomedical industry encounters numerous regulatory challenges in conducting nonclinical and ...
FDA’s START and CoGenT pilot programmes: Streamlining rare disease drug approvals
These initiatives represent a way to accelerate access to treatments that have historically faced longer regulatory pathways.
Yahoo Finance25d
Paige Adds to Regulatory Portfolio with New FDA Clearance
"This FDA clearance highlights our dedication ... "Our ability to navigate complex regulatory pathways and deliver products that meet stringent regulatory requirements reinforces our position ...
pharmaphorum5d
Boost to Enhertu's prospects as FDA clears Roche diagnostic
Roche is the recipient of the new approval, getting the go-ahead from the US regulator for its PATHWAY HER2 (4B5) test to ...
London South East17d
Update on FDA Pre-IND Meeting for Awakn
FDA endorses use of 505(b)(2) NDA pathway, enabling a streamlined regulatory process and potential for faster market access · AWKN-002 is being developed for the treatment of alcohol use disorder ...
Business Wire23d
ImmunityBio Provides Regulatory Update on Anticipated FDA Submissions in 2025 Following Meeting with the Agency
--(BUSINESS WIRE)--ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced significant progress in its ongoing discussions with the U.S. Food and Drug Administration ...