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FDA Crackdown on Trial Design: What July’s CRLs to Replimune and Capricor Mean for Sponsors

July 25th 2025

Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.

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FDA’s Elsa AI Tool Raises Accuracy and Oversight Concerns

July 23rd 2025

FDA Issues Complete Response Letter to Replimune for RP1 Combination Therapy in Advanced Melanoma
FDA Issues Complete Response Letter to Replimune for RP1 Combination Therapy in Advanced Melanoma

July 22nd 2025

ODAC Votes Against Risk-Benefit Profile of GSK’s Blenrep Combinations in Relapsed/Refractory Multiple Myeloma
ODAC Votes Against Risk-Benefit Profile of GSK’s Blenrep Combinations in Relapsed/Refractory Multiple Myeloma

July 18th 2025

Obsolete Trial Marketing Guidelines and Missing Processes Hurt Patient Enrollment
Obsolete Trial Marketing Guidelines and Missing Processes Hurt Patient Enrollment

July 8th 2025

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