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
The board has approved the settlement of US $ 248 million towards Direct Purchaser group and Retailer Opt-Out group subject to court approval
Extension of hypericin orphan designation beyond cutaneous T-cell lymphoma
The panel is headed by DCGI Dr VG Somani with representatives from various state drug regulators and health ministry
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