Historically, clinical trials have under-represented women and minorities. Clinical Trial Media's Cara Brant offers ...
The Prescription Drug User Fee Act (PDUFA) date refers to the deadline set by the US Food and Drug Administration (FDA) for reviewing a New Drug Application (NDA) or Biologics License Application (BLA ...
The trial will evaluate the safety and effectiveness of a next-generation vaccine administered through a nasal spray or ...
U.S.-based PleoPharma announced yesterday that the FDA has granted it a fast-track designation for PP-01, a new ...
Clinical trial complexity has significantly increased in the past decade. How can the industry adapt and innovate to remain ...
Phase I clinical trials are the first step in testing a new treatment or combination of treatments. These trials often ...
Lenacapavir is a twice-yearly injectable medication designed to be used as pre-exposure prophylaxis (PrEP). The FDA is giving ...
The FDA-approved international multicenter Phase 2 clinical trial will evaluate the efficacy of Liocyx-M004 as a monotherapy and in combination with lenvatinib. Lenvatinib, a well-established ...
Trial decision follows unanticipated events of elevated unconjugated bilirubin levelsCompany advancing multiple next-generation PTH1R agonists ...
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Supernus' SPN-820 Phase 2b study in treatment-resistant depression failed to meet its primary endpoint, prompting further ...
The FDA has approved two new biosimilars of denosumab-dssb to treat osteoporosis, increase bone mass, prevent ...
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