Drug Approval | December 08, 2023
Novartis receives FDA approval for Fabhalta as the first oral monotherapy for adults with PNH
Late-stage Fabhalta development program ongoing in multiple complement-mediated conditions
Late-stage Fabhalta development program ongoing in multiple complement-mediated conditions
Dr. Reddy's will make a US$ 7.5 million upfront payment to Coya
Venus Remedies is supplying the drug to many countries like Colombia, Thailand, Tanzania, Morocco, Myanmar, Indonesia, Saudi Arabia, Malaysia, Zimbabwe, Sri Lanka, Pakistan, Kenya, and Botswana
The agreement includes an upfront payment of US$15 million, regulatory and commercial milestones, and royalties
Prior to joining Alembic, he was working with Lupin Limited for more than 11 years
These regulatory approvals signify a significant milestone for Venus Remedies Limited
South Asia’s largest Trade Fair for pharma brought together over 50,000 visitors from across the globe, more than 1,500 exhibitors showcasing 10,000+ products and representation from over 80 countries
Accelerating FDA submission and confirming potential to become first approved biologic for this serious disease
Both the India and GCC entities will be operated by separate dedicated management teams
The receipt of this permission paves way for the launch of Olaparib film coated tablets in India
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