Janssen Pharmaceuticals filed a Marketing Authorisation Application with EMA to get approval for Erdafitinib. The drug is for adult patients with advanced or metastatic urothelial carcinoma, showing progression after a PD-1/PD-L1 inhibitor therapy, with susceptible FGFR3 mutations.

The FAVOUR study's interim analysis results on Alflutinib Mesylate for treating EGFR exon 20-insertion mutated NSCLC were orally presented at the 2023 WCLC. The drug is developed by Shanghai Allist Pharmaceuticals and ArriVent Biopharma.

On Sept 11, 2023, Chia Tai Tianqing Pharmaceutical launched a global phase III trial, evaluating Lanifibranor's efficacy and safety in adult NASH patients with stage 2/3 hepatic fibrosis, excluding cirrhosis.

On September 11, 2023, Abbisko Therapeutics announced that its innovative CSF-1R inhibitor pimicotinib (ABSK021) was approved by the European Medicines Agency.

Biotech firm, Phanes Therapeutics, has announced its Phase 1 clinical trial of PT217, a first-in-class drug targeting DLL3 and CD47 in small cell lung cancer. The trial uses a new IgG-like bispecific antibody and the first patient has been treated.

Biotech firm CymaBay Therapeutics, Inc. revealed positive Phase 3 trial outcomes for seladelpar, a novel treatment for liver and chronic diseases, including primary biliary cholangitis. Meeting all primary and key secondary endpoints.

Adrenomed AG has disclosed recent discoveries regarding the biomarker-directed therapy of septic shock with enibarcimab.

Daiichi Sankyo has declared that the first patient has been dosed in a first-in-human Phase 1/2 examination evaluating DS-3939.

VBI Vaccines Inc., a biopharma company specializing in immunology, announced that its cancer immunotherapy vaccine candidate, VBI-1901, has begun a Phase 2b trial in patients with first recurrence glioblastoma.

4D Molecular Therapeutics has begun the Dose Confirmation stage of their Phase 2 SPECTRA trial, enrolling their first patient. The trial evaluates intravitreal 4D-150 for treating diabetic macular edema.

FluoGuide A/S is delighted with the preliminary findings from the FG001 study concerning cancer surgery guidance in head & neck cancer patients.

Tango Therapeutics has received FDA clearance for its IND application for TNG348, a new USP1 inhibitor.