The CHMP recommends the use of niraparib and abiraterone acetate with prednisone or prednisolone (AAP), along with androgen deprivation therapy (ADT), specifically for patients with metastatic hormone-sensitive prostate
The initiative aims to speed up the development of platform-based genetic therapies for rare diseases in the US. It also aims to create a scalable model to deliver
As part of this agreement, Boehringer Ingelheim will utilise IQVIA’s data-as-a-service (DaaS+) technology to advance its global commercial data transformation, aiming to streamline data management and analytics across
The partnership will focus on creating treatments intended to restore immune homeostasis and deliver durable remission for patients, avoiding the generalised immune suppression associated with existing therapies. Under
The financing includes a €20m strategic investment from Sanofi and €40m from existing and new investors such as Artal (advised by Invus), Redmile Group, Cormorant Asset Management, Sofinnova
This designation aims to expedite the development and review of medicines for serious conditions. The FDA based its decision on comprehensive data, including findings from the Phase II
Otsuka’s NDA covers the use of centanafadine as a treatment for ADHD in adolescents, adults, and children. Centanafadine is a norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI). The
The partnership will leverage Insilico’s Pharma.AI platform for the development of small molecule inhibitors, with the agreement valued at nearly $120m. This agreement includes development and commercial milestone
Agreed in December 2025, the transaction is valued at up to $820m and brings the late-stage monoclonal antibody brelovitug, a candidate for chronic hepatitis delta virus (HDV), into
The submission relates to patients with mild cognitive impairment or mild dementia due to Alzheimer’s. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date
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