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
The FDA setback highlights ongoing tensions between patient needs, regulatory processes, and the use of real-world evidence in evaluating treatments for rare diseases
Olaparib is indicated for the treatment of certain types of ovarian, breast, pancreatic, and prostate cancers
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 company plans to use the funds to enhance its technology and forge new strategic partnerships with surgical robotics companies
Senores Pharmaceuticals (SPI) acquired 51% stake in Zoraya Pharmaceuticals
Bayer remains a key partner in Ginkgo Bioworks’ growing agricultural biologicals platform
Kygevvi combines two pyrimidine nucleosides, doxecitine and doxribtimine, which act by integrating deoxycytidine and deoxythymidine into skeletal muscle mitochondrial DNA
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