WIDAPLIK is the first and only FDA-approved triple combination medication for use as an initial therapy in patients likely to need multiple drugs to achieve blood pressure goals
This authorization follows FDA approval in June and WHO’s July recommendation adding twice-yearly lenacapavir as a PrEP option
The US generic market is crucial for Indian pharma, contributing about 35% to its total revenue, around US$ 10.7 billion
Dr. Reddy’s becomes the first pharmaceutical company to receive regulatory approval to launch Linaclotide in India under the brand name Colozo
Collaboration reinforces Boehringer Ingelheim’s expertise in microbial contract development and manufacturing
Vivo Bio Tech will have end-to-end responsibility for conducting the full spectrum of pre-clinical safety and regulatory studies
The accelerated approval is supported by results from part 1 of the ESSENCE trial
The projected business potential is around US$ 1 million in the first year
Its lead product, Dasynoc, is awaiting FDA approval with a PDUFA date of October 7, 2025
Subscribe To Our Newsletter & Stay Updated
