Full FDA approval establishes sparsentan as the first approved therapy for FSGS, addressing a longstanding reliance on ...
Exclusive global rights (excluding mainland China, Hong Kong, and Macau) position AbbVie to integrate Haisco’s early-stage ...
The guidance proposed the elimination of certain PK studies, including PK studies comparing the biosimilar to a US licensed ...
Imran Khan, Md, PhD, Vice President of U.S. medical affairs for hematology, oncologist, Johnson & Johnson, touched on ...
Deepak Prakash, VP of healthcare at Identiv, spoke with Pharmaceutical Executive, about how all of this is impacting clinical ...
In today's Pharmaceutical Executive Daily, the FDA issues a second complete response letter for Replimune's RP1 in advanced ...
Telix contributes end-to-end radiopharma capabilities, including isotope selection, radiochemistry, scalable manufacturing, and a global distribution network tailored to short half-life radioisotopes.
Opinion
FDA Issues CRL to Replimune for RP1 Biologics License Application for Advanced Melanoma Treatment
Replimune received a second FDA complete response letter for RP1 in advanced melanoma, raising questions about the viability of its oncolytic immunotherapy program. Replimune Group received a complete ...
Incorporating patient voice early can reduce burden through fewer visits, simpler procedures, and selective decentralization while maintaining trial objectives. Engagement failures commonly stem from ...
James N. Arvesen is president of the consulting firm Strategic Solutions and Services, Inc.
Citeline’s VP of commercial, patient engagement, and recruitment discusses how clinical trial design must adapt to modern issues.
In today's Pharmaceutical Executive Daily, the Trump administration delays its appeal of the federal ruling blocking RFK ...
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