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USWM, LLC (US WorldMeds) today announced that the U.S. Food and Drug Administration (FDA) has approved IWILFIN™ (eflornithine) 192 mg tablets, a groundbreaking oral maintenance therapy for high-risk neuroblastoma.

Panbela Therapeutics, Inc. (Nasdaq: PBLA) today announced that US WorldMeds®1 (USWM), a Kentucky-based specialty pharmaceutical company to whom it divested certain assets in its eflornithine pediatric neuroblastoma program, received FDA approval of its New Drug Application (NDA) for the use of eflornithine as a maintenance therapy for high-risk neuroblastoma patients who have achieved at least a partial response to certain prior therapies.

Though data became an issue in two separate meetings, the FDA’s Oncologic Drugs Advisory Committee made a potentially precedent-setting decision by voting in favor of US WorldMeds’ neuroblastoma treatment.

DMK Pharmaceuticals Corporation announced that it is reacquiring the rights to its SYMJEPI® Injection 0.3mg and SYMJEPI® Injection 0.15mg products from USWM, LLC.

Panbela Therapeutics, Inc. today announced it has divested certain assets in its eflornithine pediatric neuroblastoma program to US WorldMeds ® 1 (USWM), a Kentucky-based specialty pharmaceutical company.

ValGenesis Inc. and Trinity Bridge Professional Services LLC have partnered to extend a suite of digital validation solutions from ValGenesis to help companies in the U.S. respond rapidly to increasingly dynamic environments.