The EIR was issued with an inspection classification of Voluntary Action Indicated (VAI) post the inspection of the facility from September 16 to September 27, 2024
The primary objective of the study is to assess the safety and tolerability of SUVN-I6107 by monitoring adverse events (AEs), clinical laboratory, vital signs and electrocardiographs
The inspection, which is a routine part of the FDA's regulatory oversight, evaluates compliance with Good Manufacturing Practices and other regulatory requirements.
These three NDAs of Sitagliptin (base) and combination franchise have been approved by the USFDA earlier through the 505(b)(2) route
40th DSIR Foundation Day celebration marks 16 more technology transfers from CSIR to MSMEs
Wockhardt plans to launch Miqnaf in the Indian market in coming few months
Parkinson's disease (PD) is one of the most common neurological disorders caused by the death of dopamine-secreting neurons in the brain
The new brand name reflects the evolution from a generics-focused Contract Research Organization (CRO) to a drug development services enterprise
DOVBLERON marks the 13th addition to Innovent’s commercial portfolio
Innovent has granted Roche exclusive global rights to develop, manufacture and commercialize IBI3009
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