近日，扬厉医药、华东医药、长春高新、和誉医药等多家药企发布公告称，创新药在美国传来捷报，涉及临床试验获美国FDA受理或批准、获FDA孤儿药资格认定等。这一系列突破不仅彰显了中国药企自主研发的强劲实力，更标志着我国创新药全球化布局步入加速期，国产新药正 ...

Roche’s phase III persevERA Breast Cancer study of giredestrant in combo with palbociclib ER-positive advanced breast cancer fails to meet its primary objective: Basel Tuesday, ...

Dr Mark Kris highlights a recent study on osimertinib in NSCLC and outlines the best approaches for treatment beyond progression.

The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated unless otherwise noted. Relationships are self-held unless noted. I ...

The acquisition aims to accelerate the development of targeted therapies for EGFR mutant NSCLC patients globally.

persevERA is the first of two distinct Phase III studies in the first-line setting; the pionERA study of giredestrant in combination with physician’s choice of cyclin-dependent kinase (CDK)4/6 ...

Subcutaneous (SC) amivantamab reduces administration from hours to minutes, with efficacy and safety consistent with intravenous (IV) amivantamab1,2,3,4,5 SC amivantamab is now authorised across all ...

EGFR-positive lung cancer is more common in non-smokers (particularly those with adenocarcinoma) and younger adults, as it often develops from a single genetic mutation rather than widespread DNA ...

Topline global pivotal Phase 3 data for firmonertinib in first-line EGFR exon 20 insertion mutant NSCLC expected mid-2026Global pivotal Phase 3 ...

Roche Holdings AG RHHBY on Monday shared results from the phase 3 persevERA Breast Cancer study of giredestrant combined with palbociclib in advanced cancer patients. Trial Misses Primary Goal The ...

华东医药表示，本次注射用HDM2024美国临床试验获批，是该款产品研发进程中的又一重要进展，将进一步提升公司在肿瘤治疗领域的核心竞争力。根据美国药品注册相关的法律法规要求，药物在获得临床试验批准通知书后，尚需开展一系列临床试验并经美国FDA批准后方可上市。此次获得临床试验批准，对公司近期业绩不会产生重大影响。药品研发存在投入大、周期长、风险高等特点，临床试验进度及结果、未来产品市场竞争形势均存在诸 ...