Japanese government
FDA Grants Full Approval to Merck KGaA's Tepmetko in Advanced METex14-Altered NSCLC
The drug garnered accelerated approval from the FDA in 2021, but the agency has now granted full approval based on additional data.
Astellas Seeking Zolbetuximab Approval in CLDN18.2-Positive Gastric Cancers in Japan
The drugmaker is seeking approval for the drug in patients with advanced Claudin 18.2-expressing HER2-negative gastric cancer based on data from two trials.
FDA, Industry Taking Steps to Streamline Cell Therapy Regulation, Though Uncertainty Remains
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At two recent meetings, representatives from regulatory agencies, industry, and academia discussed ways to foster efficient, more predictable cell therapy regulation.
BMS, 2seventy's Supplemental Abecma Submissions Being Reviewed by Regulators in US, Europe, Japan
The companies have submitted data from the KarMMa-3 trial hoping to advance the CAR T-cell therapy as an earlier treatment for refractory multiple myeloma patients.
AstraZeneca's Tagrisso, Lynparza Net Adjuvant Approvals in Japan
Regulators approved Tagrisso for early-stage EGFR-mutated NSCLC patients and Lynparza, comarketed with Merck, for certain early-stage BRCA1/2-positive breast cancer patients.