Drug Approval | November 10, 2024
Granules India’s Unit V facility secures USFDA EIR with NAI status
The FDA conducted a comprehensive Pre-Approval Inspection (PAI) and cGMP audit
The FDA conducted a comprehensive Pre-Approval Inspection (PAI) and cGMP audit
Raises 2024 revenue guidance to a range of US$ 61 to US$ 64 billion
Commercial license to Synaffix technologies follows a series of successful initial preclinical proof of concept studies
The inspection concluded with the issuance of Form 483 with four observations which are procedural in nature
The INTerpath-009 clinical trial demonstrates continued expansion of the INTerpath clinical program
Potential to optimize and build on the synergies in commercial operations, distribution, manufacturing, supply chain etc.
Infant Mortality Rate in Bihar came down from 42 to 27 in 2020, and in Jharkhand, from 34 to 25 in 2020
VYALEV is the first and only subcutaneous 24-hour continuous infusion of levodopa-based therapy for the treatment of motor fluctuations in advanced Parkinson's disease
Enhertu demonstrated clinically meaningful efficacy in previously treated patients
Wockhardt's yet another novel antibiotic Miqnaf receives favourable recommendation from Subject Expert Committee of CDSCO
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