The FDA is looking to ask questions about a change of primary endpoint, treatment cessation and mortality reporting from the donanemab trial.

The prognostic factor(s) driving outcomes at the initial stages of hepatocellular carcinoma remain unclear, complicating the treatment choice.

Agomab Therapeutics has now secured a US Food and Drug Administration (FDA) orphan drug designation for IPF treatment AGMB-447.

Cycle Pharmaceuticals has proposed to acquire all issued and outstanding shares of Vanda Pharmaceuticals for $466m.

ITM Isotope Technologies Munich (ITM) has secured an investment of €188m ($204.6m) aimed at bolstering its radiopharmaceutical pipeline.

The facility is expected to allow Orano Med to produce 5,000 doses of lead-212 based radioligand therapies by 2025.

GlobalData compares how market access to healthcare in Ukraine has changed during the Russia-Ukraine conflict.

The US Food and Drug Administration (FDA) has criticised the state of Chinese pharma company Jiangsu Hengrui’s facilities in a newly released 483 form.

The company will be filing an IND for nicotinamide riboside chloride (NRC), which has received both orphan and rare pediatric designations.

GSK has acquired Elsie Biotechnologies for up to $50m to unlock the complete potential of oligonucleotide therapeutics.

The treatment is indicated for use in adults with low to intermediate-1 risk myelodysplastic syndromes with ...

BioXcel Therapeutics Inc patents a novel method for treating agitation in Alzheimer's Disease patients using sublingual dexmedetomidine, offering rapid anti-agitation effects without sedation.