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
For the full year, standalone gross revenue crossed Rs. 1,700 crore
Clears major obesity endpoints at 80 weeks
All three dose levels, 4 mg, 9 mg and 12 mg, successfully met the primary and key secondary endpoints in 80 weeks
The investment will upgrade and expand production capabilities at Lilly Lebanon API and Lilly Lebanon Advanced Therapies
The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 3 to 6 against recommending camizestrant in combination with a CDK4/6 inhibitor
The decision is based on the phase 3 DESTINY-Breast11 trial
The facility will bring 850 high-value jobs to the region, including engineers, scientists, operations personnel, and lab technicians
The FDA acknowledged that Corcept’s pivotal GRACE trial met its primary endpoint and that data from the GRADIENT trial offered confirmatory evidence
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