3SBio will receive an upfront payment of $1.25 billion and is eligible to receive milestone payments associated with certain development, regulatory and commercial milestones up to $4.8 billion
Bevqolva 25 mg/mL concentrate for infusion will be available in 4 mL (100 mg) and 16 mL (400 mg) single-use vials for infusion into veins
Accelerated approval is based on 61% overall response rate compared to 40% in control arm in the
Second FDA approval for KRAZATI - reinforcing its potential across tumor types
If approved in the European Union, Fruquintinib will be the first novel targeted therapy for Metastatic Colorectal Cancer regardless of biomarker status in over a decade
Late-breaking data to be featured in an oral presentation at the American Association for Cancer Research (AACR) annual meeting on Monday, April 8 and highlighted as part of the official meeting press program
The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 21, 2024
Versavo is the first Dr. Reddy's biosimilar product to be approved and launched in the UK
NDA supported by data from global Phase III FRESCO-2 study in the U.S., Europe, Japan and Australia along with data from Phase III FRESCO study conducted in China
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