Drug Approval | December 04, 2025
Zydus receives EIR for the injectable facility located at Jarod
This inspection was conducted following the warning letter issued by the USFDA
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
Angelini Ventures has already invested €125 million in 22 startups
LYMPHIR addresses a clear clinical need in a disease with limited treatment options
The company also revealed that MK-2214 has received Fast Track Designation from the U.S. Food and Drug Administration
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