Drug Approval | December 23, 2025
FDA go-ahead to Roche’s one-minute follicular lymphoma therapy
Full approval will depend on verification of clinical benefit in a confirmatory trial
Full approval will depend on verification of clinical benefit in a confirmatory trial
The drug is designed to improve functional capacity and reduce symptoms by inhibiting cardiac myosin motor activity
USFDA determines Sun Pharma's Baska facility inspection classification as OAI
The update promises to revolutionize laboratory workflows by optimizing resources
Patients with BRCA mutations often face aggressive disease and poor prognosis
The EIR was issued following an inspection of the facility from September 8 to September 16, 2025
The company will respond to the US FDA within the stipulated timelines
GSK holds exclusive global rights (excluding mainland China, Hong Kong, Macau, and Taiwan) from Hansoh Pharma to advance its development and commercialization
The patented product, developed by Venus Medicine Research Centre (VMRC) for the treatment of multidrug-resistant (MDR) infections, was sold to Cipla in 2019
HYMPAVZI’s safety profile was generally favorable
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