Granules Pharmaceuticals secures FDA tentative approval and 180-day exclusivity for Generic Dyanavel XR
This product has only one approved generic and one authorized generic with an addressable market share of US$ 172 million
This product has only one approved generic and one authorized generic with an addressable market share of US$ 172 million
Phase 3 study met all primary and secondary endpoints, demonstrating superior convenience, strong efficacy, and excellent safety versus conventional ondansetron injections
The supplements are made using only vegetarian-sourced ingredients
The partnership builds on a prior collaboration between Nimbus and Lilly targeting AMPK in cardiometabolic diseases
The Phase 1 study, a non-randomised, open-label, multicentre trial, is evaluating IKS014 in patients with locally advanced or metastatic solid tumours expressing HER2
The FDA designation follows visual-function results from the Phase 2 ACUITY trial
The approval follows robust data from the SWIFT and ANCHOR Phase III trials
The therapy was well tolerated through Week 24, with a safety profile consistent with Alumis’ Phase 2 data
REDEMPLO is the first and only Health Canada-approved siRNA therapy for FCS
The privately held biotech brings a first-in-class oncology program focused on small molecule–targeted protein degradation
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