A REMS may not be sufficient to address serious toxicity questions about Delcath Systems’ Melblez kit for resectable ocular melanoma that is metastatic to the liver, FDA says in briefing materials for the May 2 advisory committee review of the combination product.
The future of Delcath Systems Inc.’s Melblez Kit for resectable ocular melanoma that is metastatic to the liver appears to depend on whether the Oncologic Drugs Advisory Committee believes improvement in hepatic progression-free survival is sufficient to demonstrate clinical benefit.
The Melblez Kit, which ODAC will review May 2, contains melphalan (GlaxoSmithKline PLC’s Alkeran) and the Delcath Hepatic Delivery...
Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.
Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.
The 31 May goal date for Moderna’s next-generation COVID-19 vaccine looms over the month, but the US FDA's decision lineup includes three more novel agents, including AbbVie's Teliso-V antibody-drug conjugate, as well as supplemental indications like GSK's bid for Nucala in COPD.
Antabio’s next-generation, broad-spectrum antibacterial, MEM-ANT3310, has made it onto the European Medicines Agency’s priority medicines scheme. The company says its product is designed to make a significant impact on the growing problem of antimicrobial resistance.
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Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.
The 31 May goal date for Moderna’s next-generation COVID-19 vaccine looms over the month, but the US FDA's decision lineup includes three more novel agents, including AbbVie's Teliso-V antibody-drug conjugate, as well as supplemental indications like GSK's bid for Nucala in COPD.
