Drug Approval | May 01, 2025
USFDA inspects Marksans’s subsidiary Time-Cap Laboratories' manufacturing facility
The Subsidiary has received one inspectional observation in Form 483
The Subsidiary has received one inspectional observation in Form 483
Investment demonstrates confidence in America’s commitment to science and innovation
The inspection concluded with 6 observations and none of them were related to Data Integrity
Trastuzumab specifically binds and inhibits the human epidermal growth factor receptor 2 (HER2) protein
The new facility combines advanced technology, enhanced capacity, and holistic care, reaffirming HCG’s commitment to accessible, world-class oncology in Gujarat
DESTINY-Breast09 Phase III trial of AstraZeneca and Daiichi Sankyo’s Enhertu is the first trial in more than a decade to demonstrate superior efficacy across a broad HER2-positive metastatic patient population versus current 1st-line standard of care
Access to NIPT, TB and Rare Disease diagnostics to benefit thousands of patients nationwide
Over 1500 stakeholders representing food businesses, packaging industries, recycling associations, regulatory bodies, environmental organizations, consumer groups, farmer groups, government departments participated in the consultation
SmartTrack aims to reduce the need for clinical studies in generic drug product approvals
Anushree has been with Abbott since 2021 and currently serving as Head of Strategy and Portfolio
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