The four-hour virtual public meeting featured "incompatible" views of the FDA and sponsor on the OCEAN data, not to mention signs of impatience and resentment, with each side criticizing the positions of the other over the safety and efficacy of the multiple myeloma drug.
US Food and Drug Administration advisory committee meetings often can be dull affairs, with the product sponsor and agency reviewers methodically presenting their analyses of the data at hand before the FDA’s external experts discuss and vote on the matter.
However, the Oncologic Drugs Advisory Committee’s recent re-evaluation of the benefit-risk profile for Oncopeptides AB’s alkylating agent Pepaxto (melphalan flufenamide, or melflufen) in its current
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.
Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.
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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Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.
