Drug Approval | June 03, 2026
FDA fast-tracks Roche’s giredestrant review as data signal potential shift in early breast cancer care
The filing is backed by Phase III data from the lidERA Breast Cancer study
The filing is backed by Phase III data from the lidERA Breast Cancer study
The companies say the drug has now demonstrated clinical benefit in three separate Phase 3 trials
The transaction includes an upfront payment of $1.55 billion, along with up to $1.1 billion in regulatory and commercial milestone payments
The safety profile was described as manageable, though not without notable toxicities
While overall survival data remain immature, the results pointed to a favourable trend.
Approved as a web-based pre-diagnostic tool for suspected rare diseases and classified as a Class A (non-sterile and non-measuring) medical device
MeziKd delivered stronger response rates across multiple patient groups, including those receiving second- and third-line treatment and patients with higher-risk disease
The programme evaluated anselamimab as a first-line add-on to standard plasma cell dyscrasia therapy in patients with advanced cardiac AL amyloidosis
First-in-human study of investigational SOS1 inhibitor shows encouraging safety profile and early anti-tumor activity in patients with metastatic solid tumors
The company is set to unveil new clinical data across obesity, diabetes, kidney, and liver disease programs
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