Drug Approval | November 27, 2025
Glenmark Pharma gets VAI from FDA for Monroe facility
The positive outcome clears the way for Glenmark to resume commercial manufacturing at the site
The positive outcome clears the way for Glenmark to resume commercial manufacturing at the site
The expansion underscores Merck’s commitment to invest more than $70 billion in U.S. research, development and capital projects
Amgen has invested over $40 billion in manufacturing and research and development in US since 2017
Includes new $1.2 billion investment in manufacturing facilities, AI and advanced digital technologies, creating hundreds of highly skilled U.S. jobs
VYVGART was well tolerated, with a safety profile consistent with prior studies in AChR-Ab seropositive gMG and other indications
Investment supports Company’s plans to manufacture the vast majority of advanced medicines in the U.S. to meet the needs of patients in the U.S.
3SBio will receive a payment of $1.25 billion. Pfizer will also make a $100 million equity investment in 3SBio
The GMP-compliant facility with automated environmental monitoring accommodates both white room and class 7 and 8 cleanroom space
3SBio will receive an upfront payment of $1.25 billion and is eligible to receive milestone payments associated with certain development, regulatory and commercial milestones up to $4.8 billion
The company does not expect this development to have any material impact on the current business operations
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