The approval process was accelerated after Partner Therapeutics received the FDA Commissioner’s National Priority Voucher. Bizengri has already received breakthrough therapy and orphan drug designations for this indication.
The upgrade focuses on providing a unified and accessible framework, eliminating redundant review steps and supporting drug discovery and development projects. With this updated licensing policy, customers have
The approval is intended for adults with PsA who have had inadequate response or intolerance to previous disease-modifying antirheumatic drug (DMARD) therapy. Sotyktu can be used alone or
The location will serve as Novartis’ first RLT manufacturing site in Texas and is the company’s fifth such site in the country, increasing supply chain reach for the
The acquisition has been approved unanimously by both companies’ boards of directors, with the transaction expected to close in the third quarter of 2026. Angelini Pharma will purchase
Waiv will use its computational pathology platform to work with early phase data, which will involve analysis of tumour microenvironments using haematoxylin and eosin (H&E), as well as
Oruka has licensed the Halozyme technology for use with its lead programme, ORKA-001, which is in development to treat psoriasis and related inflammatory conditions, and up to one
The therapy is approved by the US Food and Drug Administration (FDA) for adult patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma (CTCL) following at least one prior systemic treatment. The
Following a successful tender offer and subsequent merger, the companies announced the completion of the transaction, making Terns a wholly owned subsidiary of MSD. The US Food and
Langlara is cleared for use in adults and children with type 1 diabetes mellitus (T1DM), as well as adults with type 2 diabetes mellitus (T2DM). The FDA’s decision
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