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
Eribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL) single-dose vials is the bioequivalent to the reference listed drug (RLD) Halaven injection of Eisai, Inc.
The transaction includes an upfront payment of $1.55 billion, along with up to $1.1 billion in regulatory and commercial milestone payments
The facility sets a new benchmark in respiratory diagnostics
First-in-class treatment of life-threatening, drug-resistant Acinetobacter baumannii infections advancing toward Phase II clinical proof-of-concept
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
Novel fluorescent nanosensor enables real-time detection of indole-3-propionic acid (IPA), paving the way for faster gut health screening, point-of-care diagnostics, and wearable monitoring devices
An exploratory overall survival signal also leaned in favor of the combination, though the companies noted the result remains preliminary
The safety profile was described as manageable, though not without notable toxicities
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