The approval, based on results from the Phase 3 AMPLIFY trial, marks the first all-oral, fixed-duration regimen for first-line CLL therapy
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
Bosentan 32 mg tablets for oral suspension are indicated for the treatment of Pulmonary Arterial Hypertension
The VELO system supports multiplex testing for Influenza A, Influenza B, and COVID-19, producing PCR results in six to ten minutes
The drug targets relapsed or refractory primary central nervous system lymphoma, a rare and aggressive form of non-Hodgkin lymphoma
The Pre-Approval Inspection (PAI) was completed on February 13, 2026, and the company is initiating corrective actions.
The designation for HCB101covers all forms of gastric cancer, including advanced gastric adenocarcinoma in both HER2-positive and HER2-negative patients
Iberdomide has the potential to be the first approved CELMoD agent
This approval represents the seventh FDA-approved companion diagnostic indication for PD-L1 IHC 22C3 pharmDx with KEYTRUDA
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