Johnson & Johnson Files sBLA for Darzalex Faspro Combination in Multiple Myeloma
January 31st 2024FDA to evaluate Darzalex Faspro with bortezomib, lenalidomide, and dexamethasone for induction and consolidation treatment and with lenalidomide for the maintenance treatment of adults newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant.
Approval Sought for Keytruda/Padcev Combination for First-Line Treatment of Urothelial Cancer
January 31st 2024FDA to evaluate Padcev (enfortumab vedotin) with Merck’s Keytruda (pembrolizumab) for the first-line treatment of adults with previously untreated locally advanced or metastatic urothelial cancer.
Gammagard Liquid Gets FDA Approval for Chronic Inflammatory Demyelinating Polyneuropathy
January 30th 2024Gammagard Liquid is now FDA-approved to treat neuromuscular disability and impairment in adults with CIDP; as a replacement treatment for primary immunodeficiency in patients aged 2 years and older; and as a maintenance treatment to improve muscle strength and disability in adults with multifocal motor neuropathy.
Indication for Zynrelef Expanded to Include Orthopedic, Soft Tissue Procedures
January 25th 2024Zynrelef was initially approved by the FDA for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours following bunionectomy, open inguinal herniorrhaphy, and total knee arthroplasty.