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.
Roche Ends Agreement With Repare Therapeutics to Develop ATR Inhibitor Camonsertib
February 13th 2024Roche halts agreement with Repare Therapeutics to develop and commercialize camonsertib just weeks after triggering a $40 million milestone payment when the first patient was dosed with the novel cancer drug.
Jonathan Miller, General Counsel, US Hemp Roundtable Discusses FDA Regulation of the Hemp Market
February 8th 2024In an interview with Pharm Exec Associate Editor Don Tracy, Jonathan Miller, General Counsel, US Hemp Roundtable, discusses recent efforts that urge the House Energy and Commerce Committee to expedite an FDA hearing on the hemp market.