Breakthrough Therapies
Because the primary intent of Breakthrough Therapy designation is to develop evidence needed to support approval as efficiently as possible, FDA ...
Breakthrough Therapies - Friends of Cancer Research
Indication: Treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) who have experienced disease progression following ...
Frequently Asked Questions: Breakthrough Therapies - FDA
A breakthrough therapy designation is for a drug that treats a serious or life-threatening condition and preliminary clinical evidence indicates ...
About Breakthrough Therapies - Friends of Cancer Research
A new drug may be designated as a breakthrough therapy if it is intended to treat a serious or life-threatening disease and preliminary clinical evidence ...
Breakthrough therapy designation: The real-world impact of ... - CAS
... therapies. Once designated as breakthrough therapies, investigational drugs receive intensive FDA guidance on an efficient drug development program, an ...
Breakthrough therapy - Wikipedia
Breakthrough therapy ... Breakthrough therapy is a United States Food and Drug Administration designation that expedites drug development that was created by ...
When are breakthrough therapies cost-effective? - PMC
Overall breakthrough therapies had lower, ie, more favorable, CE ratios (means of $189,000/QALY vs $234,000/QALY), with larger QALY gains (means of 1.1 vs 0.87) ...
What Is an FDA Breakthrough Therapy Designation?
Learn how the FDA's Breakthrough Therapy Designation accelerates the development of promising treatments for serious conditions, ...
FDA Breakthrough Therapy Designation Reduced Late-Stage Drug ...
This landing page presents the abstract of a paper published in Health Affairs. The full text of the article is available at: ...
Accelerated Approval and Breakthrough Therapy Designation
Accelerated approval and Breakthrough Therapy Designation hold the promise of making new treatments available sooner through the use of smaller studies ...
US FDA breakthrough therapy designation and consumer drug ...
Neeraj G Patel and colleagues examine how drugs approved through the FDA breakthrough pathway are advertised to consumers and argue that the name contributes ...
Expediting Drug Development — The FDA's New “Breakthrough ...
The breakthrough-therapy designation has since been introduced into the FDA portfolio of expedited programs for serious conditions. The genesis of the new ...
Premarket Pivotal Trial End Points and Postmarketing Requirements ...
Therapeutics that are granted breakthrough therapy designation can receive accelerated or traditional approval; however, little is known about ...
S.5123 - Breakthrough Therapies Act 117th Congress (2021-2022)
Summary of S.5123 - 117th Congress (2021-2022): Breakthrough Therapies Act.
Breakthrough Therapy Designation | Health Affairs
A drug candidate may be designated by the FDA as a "breakthrough therapy" if early clinical evidence indicates that the drug may demonstrate a substantial ...
List of drugs granted breakthrough therapy designation - Wikipedia
Drugs granted breakthrough therapy designation (BTD) by the US Food and Drug Administration (FDA). Drugs may be listed more than once since breakthrough ...
Breakthrough therapy designation: Exploring the qualifying criteria
The workshop highlighted considerations for the BTD application process, the evaluation process, and factors for acceptance or rejection.
Breakthrough Therapies Act would enable drug development
The Breakthrough Therapies Act would pave the way for more accessible and innovative mental health treatments while also enabling state-level adaptation.
Novartis receives FDA Breakthrough Therapy designation for ...
Novartis receives FDA Breakthrough Therapy designation for investigational 177Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer ( ...
Reps. Dean and Mace Join Senators Booker and Paul to Introduce ...
The Breakthrough Therapies Act would resolve these problems by expediting the transfer of substances that receive breakthrough therapy ...