Tezepelumab granted Orphan Drug Designation in the US

Tezepelumab has been granted Orphan Drug Designation (ODD) in the US by the U.S. Food and Drug Administration (FDA) for the treatment of eosinophilic esophagitis (EoE)

US FDA grants Soligenix Orphan Drug Designation for the treatment of T-cell lymphoma

Extension of hypericin orphan designation beyond cutaneous T-cell lymphoma

US FDA grants Lantern Pharma additional Orphan Drug tag for LP-184

The drug is also intended for the treatment of glioblastoma multiforme

Takeda & Protagonist submit FDA application for groundbreaking polycythemia vera therapy

The investigational subcutaneous hepcidin mimetic peptide is designed to regulate iron and red blood cell production

Savara resubmits FDA application for potential treatment in rare lung disease patients

The resubmission of BLA for MOLBREEVI names Fujifilm as the drug substance manufacturer

Diamyd Medical accelerates Phase 3 Type 1 diabetes trial following FDA guidance

The interim efficacy readout, involving around 170 participants with 15-month data, remains on track for the end of March 2026

CPHI & PMEC India 2025 ignites pharma innovation and partnerships

For 2026 onwards, CPHI and PMEC India are evolving into two distinct, specialized shows

US House passes Bill reauthorizing FDA rare disease incentive program

Chugai’s Tecentriq gets green light in Japan for hard-to-treat Thymic Carcinoma

The drug had previously received orphan drug designation for this rare cancer on March 31, 2025

EU nod to Wayrilz as breakthrough treatment for hard-to-treat ITP

Wayrilz represents a new approach to ITP by targeting the disease at its root through multi-immune modulation