FDA grants Orphan Drug Designation for Tinostamustine in malignant glioma
Tinostamustine is an investigational drug with a potential first-in-class mechanism combining bifunctional alkylating activity and pan histone deacetylase (HDAC) inhibition
Tinostamustine is an investigational drug with a potential first-in-class mechanism combining bifunctional alkylating activity and pan histone deacetylase (HDAC) inhibition
Agreements mark a major victory in the President’s long-term pledge to lower prescription drug costs for Americans
Enabling a new era in minimally invasive obesity treatment across Europe
This approval is based on positive results from two Phase 3, global, double-blind, placebo-controlled trials
Relmada expects to initiate its Phase 3 program in the first half of 2026
The FDA setback highlights ongoing tensions between patient needs, regulatory processes, and the use of real-world evidence in evaluating treatments for rare diseases
The discussions come as part of the administration’s broader efforts to drive down drug prices and increase patient access to essential therapies
The integration of AHG’s specialized cold chain transportation and third-party logistics (3PL) solutions will significantly strengthen UPS Healthcare’s service offerings
Orphan drug designation (ODD) by the USFDA for Desidustat, provides eligibility for a potential seven-year marketing exclusivity subject to the USFDA approval
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