HAI Solutions has received De Novo classification from the U.S. Food and Drug Administration (FDA) for its QIKCAP System, making it the first ultraviolet light-based microbial reduction device to be granted such approval for use with needleless luer-activated IV connectors. The FDA decision establishes a new Class II medical device category, placing the QIKCAP platform
Co-Diagnostics, Inc. has received its first international patent for its Co-Dx PCR platform, with the Australian Patent Office granting coverage for the point-of-care molecular diagnostics system, including its PCR Pro instrument and disposable test cups. This development marks a critical step in the U.S.-based company’s international intellectual property strategy as it advances toward global commercialization
The recent FDA approval of Rubraca (rucaparib) for pre-chemotherapy use in BRCA-mutated metastatic castration-resistant prostate cancer marks a strategic inflection for the field. This expanded indication, driven by head-to-head superiority over docetaxel in the TRITON3 Phase 3 trial, positions BRCA mutations as the first molecular biomarker in prostate cancer to carry actionable, label-defining weight in
Discover how biotech startups are targeting the regulome—the cell’s regulatory code—to unlock new drug targets beyond the genome and proteome.
For much of the past two decades, monoclonal antibodies have dominated modern drug development. Their ability to bind with high specificity, block protein function, and engage immune mechanisms has transformed the treatment of cancer, autoimmune disorders, and infectious disease. But despite their blockbuster status, biologics have a blind spot. They are largely excluded from the
Sanofi to acquire Dynavax for $2.2B to boost adult vaccines. Find out how HEPLISAV-B and Z-1018 fit into Sanofi’s global immunization strategy.
As 2026 begins, a new class of biotechnology companies is gaining prominence, not for any single drug, but for how they discover them. These firms, often referred to as AI-native biotechs, are reengineering the drug discovery process around machine learning. Unlike traditional pharmaceutical companies that apply algorithms to specific decision points in an existing workflow,
Mabwell Biopharmaceuticals has received Investigational New Drug (IND) clearance from the United States Food and Drug Administration to initiate a Phase IIa clinical study for its anti-ST2 monoclonal antibody, 9MW1911, in patients with moderate-to-severe chronic obstructive pulmonary disease. This regulatory milestone comes on the heels of a completed Phase IIa study in China, where Mabwell
Biohaven Ltd. has reported that BHV-7000, its experimental Kv7 ion channel modulator, failed to meet the primary endpoint in a Phase 2 proof-of-concept trial evaluating the drug in patients with major depressive disorder. The trial assessed changes in depressive symptoms using the Montgomery-Åsberg Depression Rating Scale over six weeks compared to placebo. Although some numerical
The class of poly (ADP-ribose) polymerase inhibitors, once celebrated as a breakthrough in ovarian and breast cancer, has endured a reputation decline following safety concerns and regulatory rollbacks. But recent data suggest that prostate cancer, specifically metastatic castration-resistant prostate cancer with BRCA mutations, may offer PARP inhibitors a new lease on life. The December 2025