Drug Approval | May 30, 2026
FDA delays AstraZeneca decision on camizestrant as regulators seek more data
The filing is backed by results from the pivotal SERENA-6 Phase III trial
The filing is backed by results from the pivotal SERENA-6 Phase III trial
Hikal’s Q4 profit remained sharply lower year-on-year, falling 71% from Rs. 50.2 crore in Q4 FY25 as the company absorbed regulatory pressures and strategic accounting adjustments
The decision marks a key step in the centralized EU review process
The approval was granted by Agenzia Italiana del Farmaco
The product has received tentative USFDA approval, Health Canada notice of compliance, and Indian regulatory approval
The two companies will establish a joint Center of Excellence (CoE) in Bengaluru
The renewal covers two versions of the IQOS device and three HEETS tobacco variants
Stroke is the second-leading cause of death and the third-leading cause of disability worldwide
The twin designations are designed to speed up the development and review of promising medicines targeting serious conditions with high unmet need
Company confirms seized products were not from its authorised supply chain and urges patients to purchase medicines only through licensed pharmacies
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