An Iowa watchdog group says the EPA has stalled, or even scuttled, a nitrate review tied to health risks in drinking water.
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Roche gets FDA priority review for Enspryng in thyroid eye disease
Roche RHHBY announced that the FDA has accepted and granted priority review to its supplemental biologics license application ...
Priority review positions satralizumab as a potentially practice-shifting alternative to IV IGF-1R inhibitors, primarily differentiated by subcutaneous self-administration and at-home dosing. Two ...
Backed by data from the phase 3 SatraGO trials, satralizumab has the potential to offer patients a convenient, at-home treatment option.
The FDA granted priority review to a supplemental biologics license application for Enspryng for thyroid eye disease, ...
Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review to a supplemental ...
Lumvoa (veligrotug-vvze) is now FDA-approved to treat thyroid eye disease regardless of activity or duration, offering a new therapeutic option for both active and chronic phases. The Food and Drug ...
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Viridian secures first FDA approval, sets up challenge to Amgen's Tepezza for thyroid eye disease
The U.S. Food and Drug Administration on Friday approved Viridian Therapeutics Inc.’s VRDN new thyroid eye disease (TED) ...
Viridian Therapeutics’ Lumvoa is the first FDA-approved treatment for thyroid eye disease that includes data for both active and chronic forms of the illness. The FDA has signed off on Viridian ...
As the second half of 2026 begins, a series of regulatory approvals, strategic acquisitions, clinical development milestones, and financing initiatives are highlighting continued activity across the ...
FDA labeling covers active and chronic TED, addressing a major evidentiary gap left by prior IGF-1R inhibition programs that primarily enrolled active disease populations. Two pivotal phase 3 trials ...
Viridian Therapeutics, Inc. (Nasdaq: VRDN), a biotechnology company focused on discovering, developing, and commercializing potentially best-in-class medicines for autoimmune and rare diseases, today ...
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