Drug Approval | December 04, 2025
FDA expands nod of Eli Lilly’s Jaypirca for earlier CLL/SLL treatment
Jaypirca is the first and only FDA-approved non-covalent (reversible) BTK inhibitor
Jaypirca is the first and only FDA-approved non-covalent (reversible) BTK inhibitor
The company introduced the ExcelSign E12 and E17 modular patient monitors, the Relife 1000 biphasic defibrillator, and a new OT charting software
PLI scheme for Bulk Drugs has a total budgetary outlay of Rs. 6,940 crore
This inspection was conducted following the warning letter issued by the USFDA
FDA's withholding of the PRV was contrary to law because no drug product containing phenobarbital sodium was 'previously approved'
The deal aims to address long-standing imbalances in pharmaceutical trade while boosting investment and innovation on both sides of the Atlantic
Despite steep funding setbacks, the global HIV response has gained momentum in 2025 with the introduction of twice-yearly injectable LEN
The acquisitions merge DatCard and Sorna’s expertise in clinical data sharing with Avandra’s de-identified patient data aggregation platform
Health Canada’s approval was based on a comprehensive evaluation of analytical, nonclinical, and clinical data
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