FDA recommends inclusion of patients as young as 6 months – younger than Moleculin had proposed – to be allowed in the pediatric clinical study Enrollment and dosing are ongoing in pivotal, adaptive ...

Developing Therapeutics for the Treatment of CNS Disorders, Specifically Suicidal Bipolar Depression, Chronic Pain and PTSD. Alignment on Initial Pediatric Study Plan is a Gating Requirement for ...

INTENT Biologics Receives FDA Agreement Granting a Full Waiver for its Pediatric Study Plan for PEP Biologic™ in Advanced Wound Care INTENT Biologics, a clinical-stage biotechnology company developing ...

(RTTNews) - NRx Pharmaceuticals, Inc. (NRXP), Monday announced that along with HOPE Therapeutics, Inc., the company would align with the U.S. Food and Drug Administration on an initial Pediatric Study ...

Moleculin Biotech, Inc. has announced progress regarding its drug Annamycin, designed to eliminate the cardiotoxicity often associated with anthracyclines used in cancer treatments, especially in ...

INTENT Biologics, a clinical-stage biotechnology company developing PEP Biologic as the first-in-class exosome-based biologic therapies for serious conditions with significant unmet medical need, ...