April 18th 2024
According to results of the study, 46% of patients with giant cell arteritis administered Rinvoq achieved sustained remission from weeks 12 to 52.
FDA to Evaluate BeiGene’s Tevimbra Combination for Gastric/Gastroesophageal Junction Adenocarcinoma
February 27th 2024Trial data support Tevimbra combined with chemotherapy as a potential first-line treatment option for patients with locally advanced, unresectable or metastatic gastric or gastroesophageal junction cancer.
Bayer Granted FDA Breakthrough Therapy Designation for Non-Small Cell Lung Cancer Drug
February 26th 2024BAY 2927088 is an oral, reversible small molecule tyrosine kinase inhibitor being analyzed for the treatment of unresectable or metastatic non-small cell lung cancer with tumors that have activating HER2 mutations.
FDA Grants Priority Review to Dupixent for Uncontrolled Chronic Obstructive Pulmonary Disease
February 23rd 2024The FDA has assigned a supplemental Biologics License Application submitted by Regeneron and Sanofi for Dupixent in the treatment of COPD with type 2 inflammation with a PDUFA date of June 27, 2024.
FDA to Evaluate BLA for Datopotamab Deruxtecan in Non-Small Cell Lung Cancer
February 20th 2024The FDA set a Prescription Drug User Fee Act date during Q4 of 2024 for the biologics license application for datopotamab deruxtecan in patients with previously treated advanced nonsquamous non-small cell lung cancer.
Bristol Myers Squibb Seeks Approval for Opdivo Regimen in Resectable Non-Small Cell Lung Cancer
February 7th 2024Results from the Phase III CheckMate -77T trial show that Opdivo (nivolumab) plus chemotherapy followed by surgery and adjuvant Opdivo produced statistically significant and clinically meaningful improvements in event-free survival in patients with resectable stage IIA to IIIB non-small cell lung cancer.