Enhertu cut breast cancer recurrence risk by 53% against T-DM1, but will lung toxicity affect its use?
Enhertu wins EU approval after cutting invasive recurrence or death risk by 53% versus T-DM1. Lung toxicity remains a key consideration.
Pharma & Biotech
Pharma & Biotech
Olorofim Phase 3 results show fewer kidney complications in patients with invasive aspergillosis
F2G and Shionogi's oral olorofim meets Phase 3 aspergillosis endpoint with fewer kidney adverse events. Explore the results and FDA plans.
Pharma & Biotech
Ionis TRYNGOLZA wins EU recommendation after 85% reduction in pancreatitis events
European regulators have recommended extending TRYNGOLZA to adults with fasting triglycerides of at least 880 mg/dL. The decision follows two Phase 3 trials demonstrating substantial triglyceride reductions and 85% fewer adjudicated acute pancreatitis events in a pooled analysis.
Pharma & Biotech
Omeros faces second European rejection for YARTEMLEA despite US approval
The EMA's CHMP has maintained its negative opinion on narsoplimab for transplant-associated thrombotic microangiopathy, citing unresolved clinical evidence concerns. Omeros disputes aspects of the re-examination and is shifting attention toward US commercialization and alternative patient access arrangements.
Pharma & Biotech
The FDA rejected tab-cel twice. Can Atara’s third review finally deliver approval?
The FDA has accepted Pierre Fabre's resubmitted application for tabelecleucel, setting a March 31, 2027 decision date. The review follows two rejection letters, including a January 2026 dispute over whether the ALLELE study adequately establishes effectiveness.
Pharma & Biotech
AbbVie Skyrizi achieves 35.8% endoscopic remission in Phase 3 Crohn’s disease study
New Phase 3 AFFIRM data show 35.8% endoscopic remission and 36.6% ulcer-free endoscopy with subcutaneous Skyrizi at Week 24. The findings support regulatory applications for an alternative to intravenous induction, although differences in treatment allocation after Week 12 require careful interpretation.
Pharma & Biotech
BioMarin seeks FDA approval for Voxzogo in hypochondroplasia after Phase 3 success
BioMarin presents Voxzogo skull growth research and Phase 3 hypochondroplasia data. Examine clinical evidence, FDA reviews and 2027 prospects.
Pharma & Biotech
Mirum’s EXPAND study tests maralixibat for treatment-resistant cholestatic pruritus
Mirum will reveal LIVMARLI EXPAND Phase 3 results on October 12, testing whether maralixibat can treat itching in additional rare liver diseases.
Pharma & Biotech
Why LEO Pharma is investing in real-world evidence for difficult dermatological diseases
LEO Pharma presents 21 dermatology posters covering Anzupgo, Spevigo and Adbry. Examine adolescent FDA review, clinical data and growth prospects.
Medical Devices & Diagnostics
How Guardant360 CDx detects ESR1 mutations before breast cancer progresses on imaging
Guardant360 CDx gains European CE marking for ETCAMAH patient selection. See how ESR1 blood testing changes advanced breast cancer treatment.