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Latest From Solvay SA

Wave Chasing Huntington’s Accelerated Approval Based On Caudate Atrophy Surrogate

The biotech plans a pivotal trial that would support accelerated approval of the Takeda-partnered antisense oligonucleotide, WVE-003, and will discuss it with regulators before the end of the year.

Clinical Trials Neurology

Wave Plans To Pursue Accelerated Approval For Huntington’s Drug

The biotech said it plans to engage with regulators before the end of the year for the Takeda-partnered antisense oligonucleotide, WVE-003, to discuss a pivotal trial that would support accelerated approval.

Clinical Trials Neurology

Multiple Stargardt Contenders Progress In Japan Despite Small Market

With no approved therapies globally for Stargardt's, competition in the indication is increasing in Japan, where Kubota Vision is seeking for conditional approval for emixustat, while Belite Bio’s contender tinlarebant has received Sakigake designation as a local Phase III program continues.

Japan Research & Development

Oh NOOH! Vanda’s Multi-Front Battle With US FDA Extends To Insomnia Drug Hetlioz

The notice of opportunity for hearing on the US FDA’s proposal not to approve an insomnia sNDA for Vanda’s Hetlioz opens another front in the company’s aggressive campaign against complete response letters and generic competition to the sleep disorder drug.

Drug Approval Standards Review Pathway
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Company Information

  • Industry
  • Pharmaceuticals
  • Pharmaceuticals
    • Vaccines
  • Other Names / Subsidiaries
    • Laboratories Ireland Ltd.
    • Innogenetics nv