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
First-in-class treatment of life-threatening, drug-resistant Acinetobacter baumannii infections advancing toward Phase II clinical proof-of-concept
This facility plays an important role in Granules’ global manufacturing and supply network
An exploratory overall survival signal also leaned in favor of the combination, though the companies noted the result remains preliminary
While overall survival data remain immature, the results pointed to a favourable trend.
First immunotherapy combination approved in the US for BCG-naïve high-risk NMIBC demonstrates a 32% reduction in the risk of disease recurrence, progression, or death
The safety profile was described as manageable, though not without notable toxicities
Fertility platform launches flagship clinic with advanced IVF tech
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