Pfizer Inc. has moved a step closer to reshaping the treatment paradigm for one of hemophilia’s most challenging patient subgroups. The company’s investigational therapy HYMPAVZI (marstacimab) demonstrated a 93 percent reduction in bleeding episodes in patients with hemophilia A or B who have developed inhibitors, according to data presented at the 67th American Society of
Acadia Pharmaceuticals has announced U.S. Food and Drug Administration approval for DAYBUE STIX (trofinetide) for oral solution, a new powder-based formulation of its existing drug DAYBUE used in the treatment of Rett syndrome. The approval covers use in adult and pediatric patients two years and older and is based on bioequivalence data, not new clinical
Merck has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommending an expanded indication for WINREVAIR (sotatercept) in combination with other therapies for the treatment of pulmonary arterial hypertension (PAH) in adults across WHO Functional Classes II, III, and IV. The update follows pivotal
Arcus Biosciences, Inc. has terminated its global Phase 3 STAR-221 study evaluating domvanalimab, an investigational anti-TIGIT antibody, in combination with zimberelimab and chemotherapy for advanced upper gastrointestinal cancers. The discontinuation, announced in partnership with Gilead Sciences, Inc., followed a pre-specified interim overall survival analysis that found no benefit compared to the nivolumab-based control arm. Arcus
Why this collaboration marks a turning point for AI-driven breast cancer diagnostics The ECOG-ACRIN Cancer Research Group and Caris Life Sciences have released early findings from a large-scale collaboration aimed at transforming how recurrence risk is predicted in early-stage breast cancer. Presented at the 2025 San Antonio Breast Cancer Symposium, the joint effort has produced
Lynk Pharmaceuticals and Formation Bio have entered an exclusive licensing and development agreement for LNK01006, a next-generation, central nervous system (CNS)-penetrant TYK2 inhibitor. The deal gives Formation Bio global rights to the asset outside Greater China, with plans to initiate a Phase 1 clinical trial in the United States during the first half of 2026.
Nitinotes Ltd. has begun patient enrollment in its pivotal U.S. Investigational Device Exemption study evaluating the EndoZip Automated Suturing System for endoscopic sleeve gastroplasty (ESG). The first procedure in the EASE Clinical Trial was completed at Lenox Hill Hospital | Northwell Health in New York, marking the U.S. debut of the device. This study pits
Privo Technologies has officially initiated dosing in a Phase 1/2 trial evaluating PRV131, its nanoengineered intratumoral cisplatin injectable, for the treatment of T1–T3 oral squamous cell carcinoma (OSCC). The trial, designated Arm 3 of the CLN-004 study, will explore PRV131 as a neoadjuvant therapy aimed at shrinking tumors before surgery. The announcement marks a pivotal
Senhwa Biosciences Inc. and BeOne Medicines have signed a clinical supply agreement to explore a novel drug combination aimed at treating hard-to-reach cancers. The collaboration will test Senhwa’s lead compound Pidnarulex (CX-5461), a G-quadruplex stabilizer, in combination with BeOne’s PD-1 inhibitor tislelizumab. The Phase 1b/2a clinical trial will enroll patients with advanced solid tumors, including
Zealand Pharma A/S and OTR Therapeutics have entered a multi-program strategic collaboration and licensing agreement to develop novel oral small-molecule therapies for metabolic diseases. The deal includes an initial payment of USD 20 million to OTR Therapeutics, which could increase to USD 30 million under predefined conditions. Total consideration may reach approximately USD 2.5 billion,