Bayer has revealed that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for the investigational drug elinzanetant.

Oct 12th latest updates in the global new drug development field, including progress in new drug research and development, transaction information, and partnership developments.

Teva's biosimilar of Prolia® (denosumab) has been submitted for review by the U.S. FDA and EU EMA. Prolia® is used for treating specific conditions that increase the risk of complications.

ImmuneSensor Therapeutics has begun dosing in its Phase 1 clinical trial for its primary cGAS inhibitor candidate, IMSB301.

Phanes Therapeutics has reported that the initial patient has been treated in a clinical trial involving PT886 alongside KEYTRUDA® (pembrolizumab).

Blue Earth Therapeutics pushes forward with the clinical development of Lutetium (177Lu) rhPSMA-10.1 injection, showing encouraging Phase 1 results.

Astellas and AviadoBio have signed a unique option and licensing deal for the gene therapy AVB-101, aimed at treating frontotemporal dementia and other conditions.

Merck's KEYTRUDA® (pembrolizumab) achieved its main goal of event-free survival (EFS) as a perioperative treatment for patients with resected, locally advanced head and neck squamous cell carcinoma.

Sage Therapeutics Unveils Key Findings from Phase 2 LIGHTWAVE Trial of Dalzanemdor (SAGE-718) for Mild Cognitive Impairment and Mild Dementia in Alzheimer’s Patients.

Pierre Fabre Laboratories and Scorpion Therapeutics have begun a Phase I/II clinical trial, dosing the first patient with PFL-241/STX-241.

Hiro-LS, PatSnap's biopharmaceutical AI model, integrates the proprietary PharmaGPT, a large-scale AI model with 70 billion parameters.

KaliVir Immunotherapeutics administers initial dose in Phase 1/1b trial for VET3-TGI targeting advanced solid tumors.