Decisions on the marketing authorization for Rystiggo in the European and Japanese markets are expected in Q1 of 2024
As Caeregen’s CDMO partner for CTR-107, Wacker Biotech will produce drug substance at its site in Halle, Germany, and complete clinical trial drug product production at its site in Amsterdam, the Netherlands
The company will supply materials to all global regions including Asia such as China, India, Europe, and the U.S.
Thiamine Hydrochloride Injection USP had estimated annual sales of USD 35 million in the U.S.
Based on a subgroup analysis by PD-L1 expression from KEYNOTE-811, Merck is working with the US FDA to update the current indication for KEYTRUDA in HER2-positive gastric or GEJ adenocarcinoma
The company will submit its comprehensive response on these observations to the US FDA
Panacea Biotec has announced the launch of its new range of high-quality pediatric food & nutritional products
The new range of HDPE bottles is compliant with US FDA, EU regulations and Chinese DMF registration for use in dry pharmaceutical applications
Granules now has a total of 58 ANDA approvals from US FDA
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