Drug Approval | July 06, 2025
Shilpa Pharma Lifesciences Unit-1 inspected by ANVISA
The audit has been concluded with no major observations
The audit has been concluded with no major observations
atai and Beckley Psytech plan to meet with the U.S. Food and Drug Administration (FDA) and other regulatory agencies to finalize the Phase 3 trial design.
The acquisition of Pivya is an important step in Alembic’s ability to provide branded pharmaceutical product to the US Healthcare market
Enhance strategies to drive sustainability, global Reach and digital transformation for a trillion-dollar future
ISG acknowledged Indegene's strengths in implementing holistic creative workflows, interoperability via robust integration with tech ecosystems
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
Review will evaluate effectiveness in treating alcohol withdrawal syndrome and supporting abstinence, as well as measures to mitigate risk of abuse
Changhua site meets international regulatory standards for global medical applications
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