Drug Approval | June 27, 2023
Moderna files for FDA authorization of its Covid-19 Vaccine
Supply readiness follows months of manufacturing to ensure timely and ample supply
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.
This latest audit re-emphasizes Hikal's commitment towards maintaining the best in class quality, compliance and regulatory standards across our manufacturing sites
VEOZAH is first-in-class treatment option to reduce the frequency and severity of moderate to severe VMS due to menopause
The committee voted that FDA should restrict use of LYNPARZA plus abi/pred to these BRCAm mCRPC patients
This is the first time the Agency has authorized the Phase 3 clinical evaluation in the U.S of a microbiota-based live biotherapeutic based on a pooling technology
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