European Medicines Agency

Findings presented at ESID 2026 show equivalent immunoglobulin exposure with 50% lower infusion volume in patients aged 16 and older IN BRIEFKEY TAKEAWAYSFAQs Takeda has presented detailed Phase 2/3 IgGNITE study results for investigational TAK-881 in primary immunodeficiency at ESID … Read the full press release →

Week-25 walking distance improved numerically by 17.05 metres versus placebo, while fatigue and selected subgroup outcomes showed nominal benefits IN BRIEFKEY TAKEAWAYSFAQs AstraZeneca announced Phase III HICKORY findings for investigational efzimfotase alfa in 124 treatment-naïve adolescents and adults with hypophosphatasia. … Read the full press release →

Phase III ATOMIC findings show a 50% reduction in risk of recurrence or death for Tecentriq plus mFOLFOX6 compared with chemotherapy alone. IN BRIEFKEY TAKEAWAYSFAQs Roche announced US FDA approval of Tecentriq and Tecentriq Hybreza in combination with fluoropyrimidine- and … Read the full press release →

The 76-week trial met its co-primary endpoints, with up to 13.1% average weight loss using the efficacy estimand and improvements in HbA1c, waist circumference and insulin sensitivity. IN BRIEFKEY TAKEAWAYSFAQs Boehringer Ingelheim reported positive Phase III SYNCHRONIZE-2 results for investigational … Read the full press release →

Data from the global VOYAGER study show visual and anatomical outcomes in nAMD, DME and RVO across previously untreated and treated eyes, with no new safety signals reported IN BRIEFKEY TAKEAWAYSFAQs Roche has presented new real-world results from the VOYAGER … Read the full press release →

(IN BRIEF) AstraZeneca’s Trixeo Aerosphere has been approved by the European Commission as a maintenance treatment for asthma in patients aged 12 years and older whose disease is not adequately controlled by medium-dose ICS/LABA therapy. AstraZeneca describes Trixeo as the … Read the full press release →

(IN BRIEF) Alexion, AstraZeneca Rare Disease, has received FDA Priority Review for its Biologics License Application for investigational efzimfotase alfa (ALXN1850) in patients with hypophosphatasia aged two years and older, with a regulatory decision anticipated in the first half of … Read the full press release →

(IN BRIEF) Takeda’s investigational oral TYK2 inhibitor zasocitinib has received FDA Priority Review for the treatment of adults with moderate-to-severe plaque psoriasis, with a PDUFA decision expected in the first quarter of 2027. The NDA is supported by a Phase … Read the full press release →

(IN BRIEF) Sandoz has announced a major strategic collaboration with Shanghai Henlius Biotech, Inc. covering up to 10 biosimilar assets, in one of the largest biosimilar collaborations in Sandoz’s history. Under the agreement, Sandoz will receive global commercialisation rights outside … Read the full press release →

(IN BRIEF) GSK licensor Hansoh Pharma has reported positive results from ARTEMIS-011, a pivotal phase III trial of risvutatug rezetecan, or Ris-Rez, in patients in China with relapsed osteosarcoma after at least two prior lines of systemic therapy. The trial … Read the full press release →

(IN BRIEF) Sanofi has reported that Nexviazyme met its primary and all secondary endpoints in the Baby-COMET Phase 3 study in treatment-naïve infants with infantile-onset Pompe disease. The primary endpoint assessed the proportion of participants aged six months or younger … Read the full press release →

(IN BRIEF) AstraZeneca and Daiichi Sankyo have secured European Union approval for Enhertu as a tumour-agnostic monotherapy for adults with previously treated HER2-positive IHC 3+ unresectable or metastatic solid tumours who have no satisfactory treatment alternatives. The decision is the … Read the full press release →

(IN BRIEF) Sanofi has appointed Paulo Fontoura as Executive Vice President and Global Head of Research & Development Pharma, effective September 1, 2026. Based in Paris and reporting to CEO Belén Garijo, Fontoura will join Sanofi’s Executive Committee and lead … Read the full press release →

(IN BRIEF) GSK has announced that momelotinib, a differentiated JAK inhibitor marketed as Ojjaara or Omjjara in approved indications, has received orphan drug designations from the US Food and Drug Administration and the European Medicines Agency for the treatment of … Read the full press release →

(IN BRIEF) Sanofi will stop the MOBILIZE phase 3 study of riliprubart in patients with chronic inflammatory demyelinating polyneuropathy who are refractory to standard-of-care treatment after an independent data monitoring committee determined through an interim analysis that the study was … Read the full press release →

(IN BRIEF) Sanofi has secured European Commission approval for Sarclisa® subcutaneous administration in combination with standard-of-care regimens for multiple myeloma, covering all indications already approved for the intravenous version of the therapy in the EU. The approval makes Sarclisa the … Read the full press release →

(IN BRIEF) Sanofi has received FDA priority review for the new drug application for venglustat, an investigational oral glucosylceramide synthase inhibitor being developed for type 3 Gaucher disease. The FDA’s target action date is 25 November 2026. If approved, venglustat … Read the full press release →

(IN BRIEF) EMA, together with the European Commission and the Heads of Medicines Agencies, has released the first report measuring progress toward the EU’s 2030 clinical trial targets. The report shows that 19 additional multinational clinical trials have been authorised … Read the full press release →

(IN BRIEF) Sandoz has received European Commission approval for two biosimilar insulin products, Bysumlog® (insulin lispro) and Dazparda® (insulin aspart), for the treatment of diabetes mellitus across Europe. Developed by Gan & Lee Pharmaceuticals, the products are intended to improve … Read the full press release →

(IN BRIEF) Roche has reached a key regulatory milestone with the FDA’s acceptance of its application for Gazyva/Gazyvaro as a treatment for systemic lupus erythematosus. The submission is based on strong phase III trial data showing significant improvements in disease … Read the full press release →