AstraZeneca’s Koselugo recommended for approval in the EU for Neurofibromatosis type 1

The positive opinion is based on results from KOMET, the largest and only placebo-controlled, double-blind global Phase III trial in this patient population

Glenmark signs cancer drug licensing deal with Hengrui Pharma for $18 million upfront payment

Hengrui is eligible to receive regulatory and commercial milestone payments of up to US$1.093 billion

Roche’s subcutaneous lunsumio receives CHMP backing for R/R follicular lymphoma

Moderna delivers Canada’s first locally manufactured mRNA vaccines

All drug substance for Moderna’s authorized Spikevax (COVID-19 mRNA vaccine) targeting the SARS-CoV-2 LP.8.1 variant is produced at the company’s facility in Laval, Quebec

AstraZeneca’s Tezspire recommended for approval in the EU for chronic Rhinosinusitis with nasal polyps

Tezspire nearly eliminated the need for surgery, reducing surgical intervention by 98 per cent

CuraTeQ Biologics completes Phase 3 clinical study for Denosumab biosimilar

Conducted entirely in Europe across forty sites in five countries, this rigorous study met all clinical endpoints

Roche secures CE mark for Accu-Chek SmartGuide CGM with mySugr app integration

This predictive technology empowers people with diabetes to take preventive action before complications arise

Ascletis reports positive phase Ib results for oral GLP-1R agonist ASC30 at EASD 2025

The Phase Ib MAD study is a randomized, double-blind, placebo-controlled trial conducted in the United States

AllRock Bio raises $50 million to drive therapy for pulmonary hypertension into phase 2 trials

Funding supports development of first-in-class pan-ROCK inhibitor ROC-101 through Phase 2a clinical testing

Merck opens €150 million manufacturing facility in Ireland

Merck opens first climate-neutral manufacturing facility in Ireland