The FDA has granted orphan drug designation (ODD) and RPDD to Arbor Biotechnologies' ABO-101, to treat primary hyperoxaluria ...

Ac-SSO110 has now received FDA orphan drug designation and investigational new drug application clearance for the treatment ...

Ariceum Therapeutics, a private biotech company based in Berlin, has announced that the US Food and Drug Administration (FDA) ...

A new drug reimbursement principle is seen as a significant departure from value-based pricing. Despite concerns, the new pricing system could increase the availability of some orphan drugs by 35 per ...

Ariceum Therapeutics’ proprietary radiopharmaceutical cancer therapy, 225Ac-SSO110 receives US FDA orphan drug designation: Berlin, Germany Friday, February 7, 2025, 11:00 Hrs [ ...

Ariceum Therapeutics GmbH’s radiopharmaceutical 225Ac-SSO110 ([225Ac]satoreotide tetraxetran) has been awarded orphan drug designation by the FDA for the treatment of small-cell lung cancer (SCLC).

Arbor Biotechnologies Inc.’s ABO-101 has been awarded orphan drug and rare pediatric disease designations by the FDA for the treatment of primary hyperoxaluria type 1 (PH1).

Following DSMB recommendation, the Company has voluntarily paused enrollment and dosing in the BEACON-IPF Phase 2b trial and will monitor current ...