Clinical Trials | November 10, 2025
Relmada gains FDA backing for two registrational trials and reports 92% response with NDV-01 in bladder Cancer
Relmada expects to initiate its Phase 3 program in the first half of 2026
Relmada expects to initiate its Phase 3 program in the first half of 2026
Venus Remedies now has 29 active product approvals in Vietnam alone
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 said inspection concluded with Zero Form 483 observation
Sumatriptan injection is indicated in adults for the acute treatment of migraine
The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Sprycel Tablets
A bio-analytical Remote Regulatory Assessment was also conducted from October 30 to November 7, 2025, and concluded with no observations
The device delivers clear, high-quality images to support accurate diagnoses across a broad range of patient groups
Adjusted EBITDA increased by 12.3 per cent to $531 million, up from $516 million in the same period last year
VLA1601 is a purified and inactivated vaccine specifically designed to protect against the Zika virus
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