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 study also met all secondary endpoints with a reduction in severity of VMS at weeks 4 and 12, a reduction in frequency of VMS at week 1 as well as improvements in sleep disturbances and menopause related quality of life
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
India's bio economy has experienced remarkable growth, skyrocketing from $10 billion in 2014 to over $130 billion in 2024, with projections to reach $300 billion by 2030
The company's portfolio includes 21 commercialized products, 19 approved ANDAs, 4 CGT designations, 6 filed ANDAs, and 45 products in its pipeline
Accelerated approval is based on 61% overall response rate compared to 40% in control arm in the
Afrezza, developed by MannKind Corporation in the USA, offers a needle-free, rapid-acting insulin option for diabetes management
The successful completion of RRA assessment by the USFDA, would enable company to open up its business in the USA market
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