Following the pre-NDA meeting with the U.S. FDA, the companies confirmed the current efficacy and safety databases are expected to be adequate for filing with confirmed pathways for MDD and PPD
The company claims that its Empagliflozin tablets are the most affordable in India
Abiraterone by Dr Reddy's becomes the first anti-cancer drug from India to enter the Chinese market
Tezepelumab has been granted Orphan Drug Designation (ODD) in the US by the U.S. Food and Drug Administration (FDA) for the treatment of eosinophilic esophagitis (EoE)
The applicants will only have to get their Good Manufacturing Practices certification validated every five years to retain their licence
The filing includes data from PROVENT Phase III trial showing 77% reduction in risk of developing symptomatic Covid-19 with a long-acting antibody combination (non-vaccine)
Lilly will continue to maintain its existing operating model for the remaining portfolio of products
It paves way for the launch of Selumetinib 10 mg & 25 mg capsule in India, subject to the receipt of related statutory approvals and licenses
Lonza, a global manufacturing partner to the pharma, biotech and nutrition industries, has announced it will invest in additional drug product manufacturing capabilities in Switzerland
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The council has also reduced the GST to 5 per cent on a few more Covid-19 medicines
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