The acquisition of Pivya is an important step in Alembic’s ability to provide branded pharmaceutical product to the US Healthcare market
ART-123 is a recombinant human thrombomodulin approved in Japan in 2008
A triple-action Formula for comprehensive respiratory relief
The iStent platform uses tiny surgical implants to lower eye pressure by restoring the eye’s natural fluid drainage system in patients with glaucoma
The approval in China is supported by a robust local clinical development program confirming the drug’s safety, tolerability, and efficacy profile
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
Eylea 8 mg is the first and only anti-vascular endothelial growth factor (VEGF) treatment in the EU with treatment intervals of up to 6 months for both patients with nAMD and DME
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
Changhua site meets international regulatory standards for global medical applications
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