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Regulatory
In Change That Pushed Pazdur Out, FDA May Lower Clinical Trial Requirements
Commissioner Marty Makary said that the FDA will soon start requiring only one pivotal trial, instead of two, for companies seeking approval for new drugs.
December 5, 2025
·
2 min read
·
Dan Samorodnitsky
Press Releases
OS Therapies Announces FDA PDUFA Waiver & EMA Grants Union Marketing Authorisation Eligibility
U.S. FDA grants waiver of application fee for BLA Filing of OST-HER2 Scheduled pre-Marketing Authorisation Application meeting with United Kingdom’s Medicines and Healthcare products Regulatory Agency on December 8, 2025 Scheduled Type C Meeting with United States Food & Drug Administration on December 11, 2025
December 5, 2025
·
4 min read
Press Releases
Oncology API Market Set for a Powerful Leap Towards USD 69.55 Billion Revenue
December 5, 2025
·
1 min read
Press Releases
Cell-Based Assays Market Expands Toward USD 43.9 Billion by 2035
December 5, 2025
·
1 min read
Press Releases
Cell and Gene Therapy CDMO Market Size Worth USD 74.03 Billion by 2034
December 5, 2025
·
1 min read
Press Releases
Single-Use Assemblies Market Surges Toward USD 58.44 Billion by 2034
December 5, 2025
·
1 min read
Press Releases
DNA Diagnostics Market Size Expands Toward USD 17.04 Billion as AI Revolutionizes Data Analysis, Detection Speed, and Clinical Outcomes
December 5, 2025
·
1 min read
Press Releases
Guardant Health to Present 14 Abstracts Demonstrating the Power of Multiomic Liquid Biopsy Tests in Predicting Outcomes and Tailoring Treatment for Early and Metastatic Breast Cancer at the 2025 San Antonio Breast Cancer Symposium
December 5, 2025
·
7 min read
Press Releases
Natera Acquires Foresight Diagnostics
December 5, 2025
·
5 min read
Press Releases
Viridian Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) - December 5, 2025
December 5, 2025
·
2 min read
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