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
Celecoxib Capsules approval complements Strides’ existing products to serve a broader patient base
The foray into this new segment will help Vimta to enter into the growing CDMO business of biologics and peptides
Investment demonstrates confidence in America’s commitment to science and innovation
Merck Wilmington Biotech will serve as a launch and commercial production facility and the future U.S. home for KEYTRUDA
The positive opinions are based on applications submitted by Biosimilar Collaborations Ireland Limited
Trastuzumab specifically binds and inhibits the human epidermal growth factor receptor 2 (HER2) protein
Bayer expects 2025 to be the most difficult year of its turnaround
Ami Organics’ Ankleshwar Unit II gets GMP compliant by PMDA Japan
Tolvaptan is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease
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