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 FDA designation follows visual-function results from the Phase 2 ACUITY trial
GlideTech materials are available in several standard base resins and offer customization options for specific applications
Rajdeep is an accomplished business leader with a strong techno-commercial background in the healthcare and diagnostic sector
India’s traditional medicine systems have also earned formal recognition in key bilateral trade agreements
Elanco expects Befrena to launch in the US in the first half of 2026
The approval is supported by data from three pivotal clinical trials
The decision secures legal protection in China for semaglutide, the blockbuster drug underpinning Novo Nordisk’s diabetes and obesity treatments
The trials did not show a statistically significant reduction in annualized clinical fracture rates compared to placebo or bisphosphonates
The applications aim to launch Phase Ib/II trials for relapsed/refractory multiple myeloma and primary plasma cell leukemia, respectively
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