FibroBiologics moves experimental psoriasis therapy into FDA review

The filing clears the regulatory path for potential first-in-human trials and marks a key advance in the company’s chronic inflammatory disease pipeline

FDA nod to first new motion sickness drug in 40 years

The approval is supported by data from three pivotal clinical trials

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

Establishment Labs seeks FDA nod for Motiva breast reconstruction implants

Motiva, SmoothSilk, Round and Ergonomix implants represent the latest in plastic surgery innovation

StimLabs secures FDA nod for groundbreaking human umbilical cord-derived device

Theracor is derived from human umbilical cord extracellular matrix (ECM) and is designed to cover, protect, and maintain a moist wound environment

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

INOVIO’s DNA therapy for rare throat disease gets FDA review

INOVIO remains confident in the therapy’s benefits and intends to meet with the FDA to discuss maintaining eligibility under this pathway

SN Bioscience’s SNB-101 wins FDA orphan drug designation for gastric cancer

The drug, currently in a phase 1b/2 clinical trial for small cell lung cancer, is a polymer nanoparticle formulation of SN-38

US House passes Bill reauthorizing FDA rare disease incentive program

FDA okays AQVESME as first treatment for anemia in alpha- & beta-thalassemia

The approval makes AQVESME the only FDA-approved therapy for anemia in both non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia