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 ...

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, ...

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 ...

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 ...

FDA response highlights the importance of addressing suicidal depression in adolescents age 9-17 Alignment on initial Pediatric Study Plan (iPSP) is a gating requirement for the upcoming filing of an ...

(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 ...

To include children in a clinical trial, the ethical requirements under 21 CFR 50, subpart D, the Additional Safeguards for Children in Clinical Investigations, must be considered. Clinical ...