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
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.
This facility plays an important role in Granules’ global manufacturing and supply network
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 therapy also delivered significant improvements in key liver enzyme markers
The technology enables clinicians to assess brain tissue and microvascular reperfusion directly in the angiography suite, potentially improving stroke treatment decisions and patient outcomes
Derived from rice bran wax, Licocare RBW products offer a renewable solution with a substantially lower carbon footprint than conventional montan waxes
The approval marks a major milestone in the global fight against antimicrobial resistance
The designation marks the first Breakthrough Therapy recognition for calderasib and is backed by positive results from the Phase 1 KANDLELIT-001 clinical trial
Crucially, Lupin is the exclusive first-to-file applicant for this product and is eligible for 180-day generic drug exclusivity in the U.S. market
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