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 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
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
The privately held biotech brings a first-in-class oncology program focused on small molecule–targeted protein degradation
Receiving Orphan Drug Designation is an important milestone in the clinical development of CK0804 for myelofibrosis
The therapy was well tolerated through Week 24, with a safety profile consistent with Alumis’ Phase 2 data
Blood tests measuring biomarkers such as p-tau217 are emerging as accurate, accessible alternatives
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