Hologic’s Aptima HPV test bags FDA nod for primary cervical cancer screening
Hologic has been at the forefront of cervical cancer screening for decades
Hologic has been at the forefront of cervical cancer screening for decades
The approved scheme will deliver around 1 million sq ft of state-of-the-art laboratory and research space across a 12-acre site
The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)
The findings, based on an exploratory analysis, indicate that CD47 expression may predict which patients benefit most from the therapy
N17350 is the company’s first-in-class tumor-directed therapeutic, designed to harness the ELANE pathway
The approval follows the pivotal Phase III ARANOTE trial, which demonstrated that darolutamide plus ADT cut the risk of radiological progression or death by 46% compared to placebo plus ADT
The pioneering monoclonal antibody is for Essential Thrombocythemia (ET) and Polycythemia Vera (PV), rare chronic blood cancers with limited treatment options
Pangea will use its integrated validation platform and regulatory expertise to oversee analytical and clinical validation of Gene Solutions’ multi-omics technologies.
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