The zero-observation outcome reflects the company's robust quality management systems and commitment to excellence in its operations.
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
Ensitrelvir is an oral antiviral that suppresses the replication of SARS-CoV-2 by selectively inhibiting the viral 3CL protease.
LITFULO is the first and only treatment for severe alopecia areata approved for patients as young as 12
Supply readiness follows months of manufacturing to ensure timely and ample supply
Columvi is part of Roche's industry-leading portfolio of T-cell engaging bispecific antibodies in non-Hodgkin lymphoma, which also includes the recently approved Lunsumio to treat follicular lymphoma
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
Panacea Biotec has announced the launch of its new range of high-quality pediatric food & nutritional products
Injectafer is now the first and only intravenous (IV) iron replacement therapy indicated for adult patients with heart failure who have iron deficiency
The USFDA had classified Strides Puducherry facility as OAI in May 2019 followed by issuing a warning letter to this site in July 2019.
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