The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) and rare paediatric disease designation ...
Magdalena aiming to submit Investigational New Drug (IND) application in 2025 to the FDA for a next-generation psychoactive ...
A nasal vaccine for COVID-19—based on technology developed at Washington University in St. Louis—is poised to enter a phase 1 ...
On January 7, 2025, the FDA granted priority review to the new drug application for sunvozertinib (DZD9008), an oral EGFR ...
Kura Oncology (KURA) and Kyowa Kirin announced topline results from KOMET-001, the Phase 2 registration-directed trial of ziftomenib, a highly ...
CHATHAM, N.J. - Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP), a clinical-stage biotech company with a market capitalization of $28 million, announced today positive outcomes from its Phase 1 ...
The company has already kicked off an open-label Phase I trial of ABX1100 in Canada following positive results from a study of healthy volunteers.
Long-term safety data with median follow-up of two years, and out to more than four years, demonstrate that tividenofusp alfa was generally well tolerated "Longer-term clinical data add to confidence ...
Oruka Therapeutics, Inc. (NASDAQ:ORKA), a biopharmaceutical company specializing in diagnostic substances with a market ...