Hikal announces USFDA audit with zero observations
This latest audit re-emphasizes Hikal's commitment towards maintaining the best in class quality, compliance and regulatory standards across our manufacturing sites
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 additional $50 million will go towards venture capital firms that specialize in near- and long-term healthcare solutions for patients in low- and middle-income countries
Indoco expects this change in compliance status to pave the way for approvals of ANDAs submitted from this site.
The committee voted that FDA should restrict use of LYNPARZA plus abi/pred to these BRCAm mCRPC patients
Lebrikizumab is an investigational high-affinity and potent IL-13 inhibitor being studied in adult and adolescent patients
Once approved, Columvi will be the first CD20xCD3 T-cell-engaging bispecific antibody available to treat people in Europe with this aggressive lymphoma
CEQUA is the first dry eye treatment available in India that is delivered with nanomicellar (NCELL) technology
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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