Shilpa Medicare aims for US approval of chemo nausea drug
Phase 3 study met all primary and secondary endpoints, demonstrating superior convenience, strong efficacy, and excellent safety versus conventional ondansetron injections
Phase 3 study met all primary and secondary endpoints, demonstrating superior convenience, strong efficacy, and excellent safety versus conventional ondansetron injections
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 guidelines also support reusing tenofovir and abacavir in later regimens for improved outcomes, cost savings, and programmatic efficiency
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 is the first controlled pharmacologic study to demonstrate that treatment of obesity improved PsA disease measures
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