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Results For "regulatory"

1222 News Found

Sarclisa Phase 3 trial met primary endpoint of progression free survival with newly diagnosed multiple myeloma not eligible for transplant
News | December 08, 2023

Sarclisa Phase 3 trial met primary endpoint of progression free survival with newly diagnosed multiple myeloma not eligible for transplant

Sarclisa added to bortezomib, lenalidomide and dexamethasone (VRd) significantly reduced the risk of disease progression or death compared with VRd alone


Novartis receives FDA approval for Fabhalta as the first oral monotherapy for adults with PNH
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


Dr. Reddy's inks pact with Coya Therapeutics for development of sclerosis drug
News | December 07, 2023

Dr. Reddy's inks pact with Coya Therapeutics for development of sclerosis drug

Dr. Reddy's will make a US$ 7.5 million upfront payment to Coya


Venus Remedies gets marketing approvals from Philippines, Saudi Arabia for three drugs
News | December 07, 2023

Venus Remedies gets marketing approvals from Philippines, Saudi Arabia for three drugs

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


Sun Pharmaceutical inks licensing agreement with Aclaris Therapeutics
News | December 06, 2023

Sun Pharmaceutical inks licensing agreement with Aclaris Therapeutics

The agreement includes an upfront payment of US$15 million, regulatory and commercial milestones, and royalties


Pradeep Chakravarty joins Alembic Pharmaceuticals as Head - Global Quality
People | December 05, 2023

Pradeep Chakravarty joins Alembic Pharmaceuticals as Head - Global Quality

Prior to joining Alembic, he was working with Lupin Limited for more than 11 years


Venus Remedies granted market authorizations in Saudi Arabia and Philippines
News | December 02, 2023

Venus Remedies granted market authorizations in Saudi Arabia and Philippines

These regulatory approvals signify a significant milestone for Venus Remedies Limited


CPHI & PMEC India 2023 redefines pharma landscape
News | November 30, 2023

CPHI & PMEC India 2023 redefines pharma landscape

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


Dupixent significantly reduced COPD exacerbations in second positive Phase 3 trial
Diagnostic Center | November 29, 2023

Dupixent significantly reduced COPD exacerbations in second positive Phase 3 trial

Accelerating FDA submission and confirming potential to become first approved biologic for this serious disease


Aster to separate its India and GCC businesses to unlock value
News | November 29, 2023

Aster to separate its India and GCC businesses to unlock value

Both the India and GCC entities will be operated by separate dedicated management teams