The drug’s safety profile in LIBRETTO-432 aligned with previous selpercatinib studies, showing no unexpected concerns
The NDA filing is supported by results from the phase III evERA Breast Cancer study
This approval builds on the recent transformation RYBREVANT FASPRO brought to lung cancer care
BREAKWATER is a Phase 3, randomized, open-label trial testing BRAFTOVI in combination with cetuximab, either alone or with chemotherapy, in patients with untreated BRAF V600E-mutant mCRC
Dr Adams’ lab recently uncovered a novel cellular detoxification pathway driving Cisplatin resistance in NSCLC
The designation for HCB101covers all forms of gastric cancer, including advanced gastric adenocarcinoma in both HER2-positive and HER2-negative patients
The trial, which compared Retevmo to placebo, met its primary endpoint with a “highly statistically significant and clinically meaningful improvement” in investigator-assessed EFS for patients with stage II–IIIA disease
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
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