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Biocon Biologics has gained approval from the US Food and Drug Administration (FDA) for the intravenous use of Jobevne (bevacizumab-nwgd), a biosimilar to the reference Avastin (bevacizumab).
It is planning to refile for US approval in the first quarter of 2025 after an FDA rejection last year. The company maintains that off-label bevacizumab is not held to ophthalmic quality standards ...
The US Food and Drug Administration (FDA) has approved bevacizumab-nwgd (Jobevne, Biocon Biologics Ltd), a biosimilar to bevacizumab (Avastin, Genentech), for intravenous use across multiple ...
A Prescription Drug User Fee Act target date of August ... clinicians and their patients the first and only on-label, ophthalmic bevacizumab to treat wet AMD.” A Prescription Drug User Fee ...
The FDA has approved Jobevne, a biosimilar to Avastin, for IV use in a number of cancer types. The U.S. Food and Drug Administration has approved Jobevne (bevacizumab-nwgd), a biosimilar to Avastin ...
Biocon Biologics has received the Food and Drug Administration’s green light for Jobevne (bevacizumab-nwgd), a biosimilar bevacizumab for intravenous use. Jobevne, which is a recombinant ...
(RTTNews) - Biocon Biologics Ltd (BBL), a unit of Biocon Ltd (BIOCON), Thursday said that the U.S. Food and Drug Administration (FDA) has approved Jobevne, a biosimilar to Bevacizumab. Bevacizumab ...
The U.S. FDA has approved Jobevne™ (bevacizumab-nwgd) from Biocon Biologics to treat several different types of cancer. Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd., said ...
Prescription Drug User Fee Act (PDUFA ... to offer clinicians and their patients the first and only on-label, ophthalmic bevacizumab to treat wet AMD. We are committed to bringing an ophthalmic ...
On April 10, 2025, Biocon Biologics Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved JOBEVNE™ (bevacizumab-nwgd), a new bevacizumab biosimilar referencing Genentech ...