Doxorubicin Hydrochloride Liposome Injection is indicated for the treatment of Ovarian Cancer, AIDS-Related Kaposi's Sarcoma, and Multiple Myeloma
Extended lab space for product development, customer demos, and training
Granules India receives 1 observation from USFDA for Chantilly facility
The approval in China is supported by a robust local clinical development program confirming the drug’s safety, tolerability, and efficacy profile
Acquisition to be followed by merger; strengthens Torrent’s IPM market presence
The company has been awarded a contract for the supply of essential pharmaceutical formulations to government health institutions across Rajasthan
Label updates reflect growing body of real-world evidence and regulatory confidence in the safety profile of the class of CD19- and BCMA-directed autologous CAR T cell therapies, reinforcing efforts to increase equitable access
Review will evaluate effectiveness in treating alcohol withdrawal syndrome and supporting abstinence, as well as measures to mitigate risk of abuse
The approval is based on a comprehensive package of analytical, nonclinical, and clinical data
The company's decision to withdraw the MAA was due to the timing of the availability of Chemistry Manufacturing and Controls
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