Drug Approval | October 14, 2024
Indoco Remedies receives OAI status from USFDA for Goa plant 2 & 3
Indoco is comprehensively working on the remedial action plan
Indoco is comprehensively working on the remedial action plan
Under the licensing agreement, Alkem will carry out the clinical development of “SON-080” in India with support from Sonnet and enable global and India regulatory filings
Aims to achieve CDMO sales of US$ 400 million by 2028
Clarity in regulatory frameworks and pathways help in preventing delays in accessing quality-assured, affordable medicines
India’s first trial for a novel autologous BCMA directed CAR-T cell therapy in patients with relapsed / refractory multiple myeloma
Based on ECHO Phase III trial which demonstrated Calquence combination reduced risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy
Sun Pharma will have the exclusive worldwide rights to commercialise Fibromun
HSGP is engaged closely with the USFDA and is committed to address the OAI observations through planned remediation measures
The sample seized by CDSCO is not manufactured by Torrent and is in fact non-genuine and spurious
Dupixent is indicated for the approximately 300,000 adults in the US with inadequately controlled COPD and an eosinophilic phenotype
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