Drug Approval | July 24, 2025
NATCO Pharma API unit in Mekaguda receives EIR from USFDA
The company received one observation in the Form-483
The company received one observation in the Form-483
Both these products will be manufactured at Lupin’s Injectable facility at Nagpur, India
Ibrutinib tablets will be produced at Zydus Lifesciences Ltd (SEZ), Ahmedabad
She was Group Chief Marketing Officer at CKA Birla Group in her last role
FDA requests Sarepta Therapeutics to suspend distribution of Elevidys and places clinical trials on hold for multiple gene therapy products following 3 deaths
This collaboration aims to bridge India’s talent and translational gap in this rapidly growing field by equipping professionals with practical expertise in the manufacturing of advanced therapies.
European Commission granted approval of darolutamide in combination with androgen deprivation therapy (ADT) for patients with metastatic hormone-sensitive prostate cancer (mHSPC)
Investment builds on Biogen’s 30-year history of manufacturing in the region, with approximately $10 billion invested to date
Based on the CRL, the STARGLO data do not provide sufficient evidence to support the proposed second-line DLBCL indication in the US patient population
Longer-term follow up in the FLAURA2 Phase III trial confirms the favourable benefit-risk profile of this combination
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