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Moleculin Receives Positive FDA Feedback on Pediatric Study Plan for Annamycin in Children with R/R AML

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 ...
Healio

FDA agrees on Abivax’s pediatric study plan to develop obefazimod for children with IBD

Please provide your email address to receive an email when new articles are posted on . The FDA has agreed on Abivax’s initial pediatric study plan for the development of obefazimod in children aged 2 ...
Nasdaq

Can-Fite Submits Pediatric Study Plan To Allow Registration Of Piclidenoson

(RTTNews) - Can-Fite BioPharma Ltd. (CANF) submitted a pediatric study plan to the FDA for the treatment of adolescents suffering from psoriasis with Piclidenoson. The company said the plan has been ...
Oklahoma's News

Alignment with FDA on Pediatric Study Plan and Accelerated Approval to Treat Bipolar Depression & Akathisia: NASDAQ NRXP

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 ...
Nasdaq

Moleculin Biotech, Inc. Advances Annamycin for Pediatric Cancer Treatment as FDA Approves Inclusion of Younger Patients in Clinical 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 ...
Seeking Alpha

HOPE Therapeutics, Inc. and NRx Pharmaceuticals, Inc. (Nasdaq:NRXP) Announce Alignment with FDA on Pediatric Study Plan for NRX-100 (ketamine)

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 ...