Roche obtains CE Mark for first companion diagnostic to identify patients with HER2-low metastatic breast cancer
Approximately half of all patients with metastatic breast cancer (mBC) express low levels of HER2
Approximately half of all patients with metastatic breast cancer (mBC) express low levels of HER2
The company will respond to the Warning Letter within the stipulated timelines
Doxycycline Capsules, 40 mg is indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients
Abecma tripled progression-free survival compared to standard regimens in the Phase 3 KarMMa-3 trial
Enhertu now has five approved indications with the latest in HER2-expressing (IHC 3+) metastatic cancers
The company plans to add 1700 beds by FY27 through the organic route
The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 21, 2024
First and only AKT inhibitor approved in Japan for breast cancer patients with specific biomarker alterations
Decision marks the first approval in Europe for an anti-PD-1/L1 therapy in resectable NSCLC based on positive overall survival results
USFDA inspects Zydus Lifesciences’ Ahmedabad SEZ Onco manufacturing plant
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