Menarini's Stemline Therapeutics has secured worldwide rights to Georgiamune's investigational oral cancer immunotherapy GIM-621 in a licensing agreement worth up to $1.1 billion.

The FDA has converted Keytruda's tumour-mutational-burden-high solid tumour indication to traditional approval, extending the authorisation to Keytruda Qlex and updating the biomarker threshold.

Celltrion has licensed Kaigene's next-generation anti-APRIL antibody KG013 in a global agreement worth up to $580.5 million plus royalties.

Astellas Pharma and AI Proteins have signed a research and licensing agreement worth more than $400 million in potential value to develop novel miniprotein therapeutics.

OpenAI has acquired Orchestra Bio to strengthen its life-sciences AI capabilities and develop agent-based workflows for pharmaceutical research and development.

Alcon is acquiring Neurotech Pharmaceuticals for a reported $550 million, adding Encelto and an encapsulated-cell therapy platform to its retinal disease portfolio.

The European Commission has authorised Keytruda plus Padcev before and after surgery for adults with resectable muscle-invasive bladder cancer, expanding perioperative treatment options in the EU.

The FDA has granted accelerated approval to AstraZeneca's Ultomiris for adults with primary IgA nephropathy, introducing a C5 complement inhibitor treatment to reduce proteinuria.

The FDA has approved Edwards Lifesciences' Pascal Precision system for transcatheter repair of severe tricuspid regurgitation, expanding the device's use beyond mitral valve treatment.

AmplexDiagnostics has announced a CE-IVD molecular diagnostic technology combining LAMP amplification and CRISPR-based detection for potential European diagnostic applications.

Ambrose Healthcare has acquired Netherlands-based AM-Pharma in a rare disease transaction worth up to €161 million, adding an investigational therapy for hypophosphatasia.

The FDA has approved GSK's Hibsago as the first antisense oligonucleotide treatment for chronic hepatitis B, offering eligible patients a new approach to sustained viral control.

The FDA has issued final guidance clarifying how prescription drug manufacturers should address companion apps and software in product labelling and regulatory submissions.

Eli Lilly and METiS TechBio have entered an AI-enabled lipid nanoparticle discovery collaboration carrying up to approximately $1.1 billion in potential milestone payments.

South Korea has authorised Jascayd (nerandomilast) for idiopathic pulmonary fibrosis, providing a new national treatment option for patients with progressive lung scarring.

Mankind Pharma has agreed to acquire a 70% stake in Belgium's Armed Cell Therapeutics for €48 million, marking its entry into next-generation CAR-T oncology therapies.

AstraZeneca and insitro have entered a $1.5 billion AI-enabled drug discovery collaboration targeting difficult-to-treat cardiometabolic diseases.

The FDA has cleared Stryker's Sonopet 3 ultrasonic surgical platform, introducing enhanced bone and soft-tissue removal capabilities for surgical procedures.

The UK's Medicines and Healthcare products Regulatory Agency has launched its 2030 strategy to modernise regulation of AI-enabled healthcare, medical devices and personalised medicines.

The FDA has approved Genentech's Enspryng as the first at-home subcutaneous treatment option for adults with thyroid eye disease.