The rights reversion gives Actimed full control of the muscle-wasting candidate across all indications, with amyotrophic lateral sclerosis remaining its primary development focus.

The agreement gives an undisclosed global pharmaceutical company worldwide rights to use Alteogen’s ALT-B4 technology to develop and commercialise a subcutaneous formulation of an existing biologic.

The research collaboration combines Mediar’s fibrosis biology and antibody discovery capabilities with Ono’s drug development expertise to identify new treatments targeting fibro-inflammatory disease mechanisms.

The orexin receptor agonist provides adults with a treatment that targets the underlying loss of orexin signalling rather than managing individual symptoms separately.

The stock-for-stock acquisition adds a clinical-stage neuroplastogenic pain programme to Ensysce’s pipeline, with concurrent financing expected to fund CY200 through Phase II proof-of-concept data and towards registrational development.

The proposed acquisition would add Xycota’s preclinical CNS pipeline and exosome-based delivery platform to NexTel Medical, including lead programme XYCO-01 for frontotemporal dementia.

The engineered oncolytic viral therapy, used with nivolumab, provides a new treatment option for adults with unresectable cutaneous melanoma that has progressed despite prior PD-1-based immunotherapy.

The draft guidance could reduce reliance on animal studies for some oncology products while increasing the importance of analytical characterisation and weight-of-evidence approaches during development.

The approval introduces the first messenger RNA influenza vaccine into the US market, expanding vaccine technology options for seasonal influenza prevention in older adults.

The orexin receptor agonist provides adults with a treatment that targets the underlying loss of orexin signalling rather than managing individual symptoms separately.

The all-stock transaction combines complementary central nervous system portfolios spanning neuroscience and addiction medicine, creating a larger commercial-stage company with a broader product portfolio and pipeline.

Pathos AI licenses first-in-class bispecific ADC JSKN016 from Alphamab Oncology in deal worth up to $4.8 billion

The approval adds another US biosimilar option for rituximab-treated conditions, including non-Hodgkin lymphoma and chronic lymphocytic leukaemia, although commercial availability and pricing have not yet been confirmed.

The biomarker-selected regimen adds an AKT inhibitor to abiraterone and prednisone for adults with newly diagnosed metastatic disease whose tumours show PTEN deficiency.

Recent legal and regulatory developments could influence how innovative medicines are protected in Europe by changing the interaction between regulatory exclusivity, patent rights and generic market entry.

Healthcare organisations and technology developers face an expanding mix of state laws, sector-specific FDA expectations and federal policy initiatives rather than a single nationwide AI regulatory framework.

The expanded indication moves radioligand therapy into an earlier stage of metastatic prostate cancer, providing an additional treatment option for eligible patients before progression to castration-resistant disease.

The updated vaccine is authorised for individuals aged six months and older and aligns the EU COVID-19 vaccination programme with the currently circulating XFG variant.

The two regulatory decisions could expand first-line treatment options for patients with ESR1-mutant ER-positive disease and HER2-positive metastatic breast cancer, although Enhertu still requires European Commission approval.

The room-temperature-stable product provides an alternative for adults who require plasma when conventional plasma products are unavailable, including in emergency, remote and austere settings.