FDA Grants Priority Review to Merck’s Keytruda Combo for Endometrial Carcinoma
February 21st 2024Merck seeks approval for Keytruda (pembrolizumab) plus chemotherapy with carboplatin and paclitaxel for patients with primary advanced or recurrent endometrial carcinoma, alongside chemotherapy (carboplatin and paclitaxel).
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.
FTC, HHS Launch Investigation into Role of GPOs, Wholesalers in Ongoing Generic Drug Shortages
February 15th 2024The Federal Trade Commission and Department of Health and Human Services are examining the practices of group purchasing organizations and drug wholesalers and the role they may play in triggering shortages of generic medications.