Drug Approval | September 22, 2024
Briefs: Biocon, Aarti Drugs and Glenmark Pharmaceuticals
Glenmark Pharmaceuticals Limited has informed that the USFDA has issued Form 483 with zero observations
Glenmark Pharmaceuticals Limited has informed that the USFDA has issued Form 483 with zero observations
USFDA concludes inspection of Dr. Reddy's Laboratories R&D centre in Bachupally with zero observation
New indication supported by the MANDARA trial which showed nearly 60% of patients achieved remission and 41% of patients fully stopped taking oral corticosteroids
Eugia Steriles receives EIR from USFDA for new injectable facility
India's bio economy has experienced remarkable growth, skyrocketing from US $10 billion in 2014 to over $130 billion in 2024, with projections to reach $300 billion by 2030
The sANDA was submitted as “Prior Approval Supplement” for addition of an alternate drug product manufacturing, labeling, packaging, and testing facility
ALS patients experience neuroinflammation and rapid neurodegeneration
Ami informs that PMDA Japan has issued Inspection Result Report declaring the Sachin facility as a Good Manufacturing Practices (GMP) compliant.
This Fast Track Designation will enable FDA to review MM-II in an expedited manner, is an important milestone in the development of MM-II
eGenesis is pioneering a genome engineering-based approach in the development of safe and effective transplantable organs to end the global organ shortage
Subscribe To Our Newsletter & Stay Updated
