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 new facility offers an expanded laboratory alongside meeting areas dedicated to development meetings, formulation workshops, and brainstorming sessions
The supplements are made using only vegetarian-sourced ingredients
The current two-vial format requires healthcare professionals to mix a lyophilised antigen with a liquid adjuvant before administration
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
NTX-253 is a potent, selective, orally available positive allosteric modulator (PAM) of the muscarinic M4 receptor
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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