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
Revenue increased 11.4 per cent to Rs. 8,545 crore
3SBio will receive a payment of $1.25 billion. Pfizer will also make a $100 million equity investment in 3SBio
Akums bridges the long-standing gap between paediatric syrups and conventional tablet formats
Upgrades 2025 full-year CDMO sales and margin outlook
Investment will support AstraZeneca’s ambition to reach $80 billion revenue by 2030, with 50% generated in the US
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
FDA requests Sarepta Therapeutics to suspend distribution of Elevidys and places clinical trials on hold for multiple gene therapy products following 3 deaths
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