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.
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 approval is supported by results from the Phase 3 SWOG 1826 trial
The therapy also delivered significant improvements in key liver enzyme markers
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
The filing is backed by results from the pivotal SERENA-6 Phase III trial
The approved product is the generic equivalent of Sutab® Tablets developed by Azurity Pharmaceuticals
The Establishment Inspection Report came following closure of a product- specific pre-approval inspection from March 2 to March 7, 2026
The decision clears the drug as a monotherapy for adults with unresectable, locally advanced or metastatic non-small cell lung cancer
The decision now moves to the European Commission, with a final ruling expected by the third quarter of 2026
Clearance marks major shift beyond chemotherapy
The decision marks a key step in the centralized EU review process
SFDA nod marks company’s strategic entry into high-value specialty oncology injectables as it targets expanding stem cell transplant and haemato-oncology market in the GCC region
Approved product is therapeutically equivalent to Synthroid of AbbVie and is indicated for the treatment of congenital or acquired hypothyroidism
The approval has been secured in partnership with Yabao Pharmaceuticals, a major player in China’s paediatric medicine segment
The drug is indicated for the maintenance treatment of patients with Chronic Obstructive Pulmonary Disease (COPD)
The development comes as stroke remains one of the world’s biggest health threats
AstraZeneca highlighted the move as a major step toward earlier intervention in curable disease
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