What PepGen’s 5 mg/kg FREEDOM2 cohort reveals about the risk-reward profile of PGN-EDODM1
PepGen’s FREEDOM2 data hint at PGN-EDODM1 activity in DM1, but bigger questions remain. Read what the 5 mg/kg cohort really changes.
Can Ono Pharmaceutical bring clearer treatment sequencing to advanced GIST in Japan?
Ono Pharmaceutical has filed ripretinib in Japan for advanced GIST. Read why the move could reshape late-line treatment access and sequencing.
Gilead targets durable autoimmune remission with $2.18bn Ouro Medicines acquisition
Gilead Sciences acquires Ouro Medicines for up to $2.18bn, adding BCMA T cell engager gamgertamig to its inflammation pipeline. Analysis of what the deal reveals.
Will pediatric KONFIDENT-KID data accelerate KalVista’s sebetralstat approval in hereditary angioedema?
KalVista’s sebetralstat pediatric trial data heads to Madrid. What it means for the HAE on-demand market and a 2026 FDA filing. Read the analysis.
IntraBio leverages prior Niemann-Pick approval to seek FDA expansion of levacetylleucine into Ataxia-Telangiectasia
IntraBio files the first-ever FDA application for an A-T therapy. Analyse the Phase III evidence, regulatory pathway, and what approval would mean.
Curatis licenses corticorelin to Neupharma in CHF 83.5m Japan deal
Curatis and Neupharma sign a CHF 83.5m Japan licensing deal for corticorelin in peritumoral brain edema. Read our analysis of what the deal means.
United Therapeutics targets 2026 FDA submission for Tyvaso IPF indication after TETON-2 success
TETON-2 phase 3 data show nebulized treprostinil slows IPF lung decline and cuts clinical worsening risk. Analysis of what the NEJM results mean.
Hansa Biopharma files BLA for imlifidase in kidney transplant desensitization: What this changes for U.S. patients
Hansa Biopharma files for FDA approval of imlifidase to enable kidney transplants in highly sensitized patients. Find out what changes next.
How Hansa Biopharma is targeting a transplant blind spot with Imlifidase
Hansa Biopharma AB has submitted a Biologics License Application to the U.S. Food and Drug Administration for imlifidase as a desensitization treatment in highly sensitized adult patients awaiting deceased donor kidney transplants. The submission is supported by the pivotal Phase 3 ConfIdeS trial, and the company is seeking a priority review that could lead to […]