If approved, Ameluz would become the first and only photodynamic therapy (PDT) photosensitizer for sBCC in the US
This approval represents the seventh FDA-approved companion diagnostic indication for PD-L1 IHC 22C3 pharmDx with KEYTRUDA
KEYTRUDA QLEX is contraindicated in patients with known hypersensitivity to its components
The therapy is currently completing Phase 1 clinical trials in renal cell carcinoma and non-small cell lung cancer
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
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