AQUIPTA® (atogepant) is now approved in the European Union for the acute treatment of migraine in adults, with or without aura, and for the prophylaxis of migraine in adults who have at least four migraine days per month. Approval was based on the pivotal Phase 3 ECLIPSE trial, which showed that AQUIPTA resulted in statistically significant pain freedom at two hours versus placebo during the first migraine attack, with sustained pain freedom from 2 to 48 hours and a clinically meaningful and con

China’s NMPA has granted marketing approval to eratrectinib (VC004), a next-generation TRK inhibitor developed by Nanjing-based Jiangsu Vcare PharmaTech Co., Ltd., for adult and adolescent patients with advanced solid tumors harboring NTRK gene fusions. The tumor-agnostic approval is notable for extending coverage to patients who have progressed on first-generation TRK inhibitors — a population for whom treatment options remain limited — and represents the first domestically developed next-gener

Two regimens containing Celcuity's multi-target PAM inhibitor gedatolisib halved the risk of disease progression or death versus Novartis' PI3Kα inhibitor Piqray (alpelisib) in adults with hormone receptor (HR)-positive, HER2-negative, PIK3CA mutated, locally advanced or metastatic breast cancer. The statistically significant and clinically meaningful findings come from the Phase III VIKTORIA-1 trial, which were presented Tuesday at the American Society of Clinical Oncology (ASCO) annual meeting

Emi-Le recently received Breakthrough Designation from the U.S. Food and Drug Administration (FDA) for the proposed treatment of patients with locally advanced, recurrent or metastatic ACC with solid histology or high-grade transformation Oral presentation shows Emi-Le was well tolerated and showed promising signals of efficacy among 45 evaluable participants with ACC June 1, 2026 -- Servier today announced promising new Phase 1 clinical data for Emi-Le, an investigational antibody drug conjuga

ZAYNICH is a multi- penicillin-binding protein targeting combination of the 4th generation cephalosporin cefepime and zidebactam working synergistically against the most challenging multidrug-resistant Gram-negative bacteria In the Phase 3 ENHANCE-1 clinical trial, ZAYNICH demonstrated higher combined clinical cure and microbiologic response (composite endpoint) at the test of cure (TOC) visit versus meropenem, 89.0% vs 68.4% respectively and was generally well tolerated More than 2.8 million an

June 1, 2026 -- SystImmune, Inc., a clinical-stage biotechnology company, today announced the oral presentation of Phase 1 data for BL-M14D1 in patients with small-cell lung cancer (SCLC), neuroendocrine carcinoma (NEC), and other solid tumors (BL-M14D1-101, NCT06505824) at the American Society of Clinical Oncology (ASCO) 2026 Annual Meeting in Chicago. BL-M14D1 is a DLL3 targeting antibody drug conjugate being developed globally by SystImmune, a subsidiary of Biokin. This study evaluated the

BHV-8100 is an orally administered, brain-penetrant PKM2 modulator; a novel therapeutic class addressing the bioenergetic and immunometabolic basis of systemic and central nervous system disorders First-in-human study initiated with dose escalation ongoing; preliminary data in healthy participants demonstrates favorable pharmacokinetics supporting convenient, once-daily dosing and well a tolerated profile at projected therapeutic exposures Penetrates blood-brain barrier and reverses metabolic

While a regimen involving Pfizer's Talzenna (talazoparib) and androgen receptor pathway inhibitor Xtandi (enzalutamide) is already approved for patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC), the pharma is looking to move the duo into a new population — metastatic castration-sensitive prostate cancer (mCSPC), also known as metastatic hormone-sensitive prostate cancer — and now it has the data to back up its ambitions. At

In a new study, which was published last week in Frontiers in Oncology, scientists from Oncolines, together with researchers from Vrije Universiteit Amsterdam, describe differentiators and a potential new therapeutic application for Bruton’s Tyrosine Kinase (BTK) inhibitor nemtabrutinib [1]. Currently, four BTK inhibitors are approved for treatment of B-cell malignancies. The three approved covalent BTK inhibitors ibrutinib, acalabrutinib and zanubrutinib bind irreversibly to the active site of

Merck (NYSE: MRK) announced receipt of US FDA Breakthrough Therapy Designation (BTD) for calderasib (MK-1084), an oral next-generation KRAS G12C covalent inhibitor. The BTD covers the molecule’s use in combination with pembrolizumab (Keytruda), for the first-line treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC) harboring a KRAS G12C mutation and expressing PD-L1 with a tumor proportion score (TPS) ≥1%. The designation, the first awarded to calderasib, was supp