Regulatory news Normativa europea 4 aprile 2025 EMA Reflection paper on patient access to electronic product information (ePI) from EU medicine packages
Prodotti competitors / Area Oncology 21 marzo 2025 FDA approves pembrolizumab for HER2 positive gastric or gastroesophageal junction adenocarcinoma expressing PD-L1 (CPS ≥1)
Prodotti competitors / Area Oncology 21 marzo 2025 FDA granted traditional approval to Keytruda for HER2+PD-L1+ gastric or GEJ adenocarcinoma
Regulatory news 19 marzo 2025 FDA publishes updated Guidance on the accelerated Drug Approval Process for serious Diseases
Prodotti GS / Area HIV 14 marzo 2025 Pharmacokinetics and safety of once-yearly lenacapavir: a phase 1, open-label study
Prodotti competitors / Area Onco-Ema, Area Kite 28 febbraio 2025 J&J’s DARZALEX (daratumumab) subcutaneous-based regimen receives positive CHMP opinion for patients with newly diagnosed multiple myeloma, regardless of transplant eligibility
Prodotti competitors / Area Oncology 26 febbraio 2025 New Merck Phase 3 trial (TroFuse-011) assessing sacituzumab tirumotecan ± pembrolizumab in 1L metastatic Triple Negative Breast Cancer (mTNBC)
Prodotti competitors / Area Kite, Area Onco-Ema 17 febbraio 2025 Positive Topline Results for Breyanzi (lisocabtagene maraleucel) in Adult Patients with Relapsed or Refractory Marginal Zone Lymphoma
