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
The current two-vial format requires healthcare professionals to mix a lyophilised antigen with a liquid adjuvant before administration
The guidelines also support reusing tenofovir and abacavir in later regimens for improved outcomes, cost savings, and programmatic efficiency
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 is backed by data showing deep, durable responses and manageable tolerability
This drug candidate, which is currently progressing through pivotal clinical studies, has the potential to become the first add-on therapy for schizophrenia patients who do not respond adequately
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