Drug Approval | January 17, 2022
Strides receives USFDA approval for influenza medicine
The company has 271 cumulative ANDA filings with USFDA of which 243 ANDAs have been approved and 28 are pending approval
The company has 271 cumulative ANDA filings with USFDA of which 243 ANDAs have been approved and 28 are pending approval
The company has 47 ANDA's pending approval with the U.S.FDA
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CuraTeQ and Orion had entered into a licensing agreement, granting marketing and distribution rights for CuraTeQ’s biosimilar products under development in the Nordic states, Austria, Hungary and Slovenia
It is indicated for the treatment of patients with acromegaly and Gastroenteropancreatic Neuroendocrine Tumours
First Emergency Use Listing granted by WHO for a protein-based Covid-19 vaccine
Ichnos will receive an upfront payment of Euro 20.8 million as well as additional development and commercial milestone payments and tiered royalties based upon future global sales
The group now has 325 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04.
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Primary endpoints and secondary endpoints for which data are available were met in trial dominated by Covid-19 variants
Lupin had earlier received the U.S. FDA acceptance of the Biologics License Application (BLA) for Its proposed biosimilar
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