Oncopeptides Weighing Pepaxto Withdrawal Request
Drama continues for the multiple myeloma treatment as US FDA formally moves to pull accelerated approval. Oncopeptides anticipates making a decision on the request in the first quarter of 2023.
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Accelerated Approval Reforms Give US FDA More Power And Flexibility – With Some Gaps
Pending legislation will give agency ability to require that confirmatory studies be underway at time of approval and expedited withdrawal process could allow FDA to skip a second advisory committee meeting, but Congress holds back on some agency requests for expanded authority.
Pepaxto Adcom Saw Public Airing Of Unusual Level Of Discord Between US FDA, Oncopeptides
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.
After ‘Clean’ User Fee Renewal, Will Programs Held Hostage Be Enough To Drive A Broader Reform Bill?
Continuing resolution will force lawmakers back to the bargaining table before year end. Orphan grants and pediatric exclusivity are among the programs left out of the short-term spending measure as Congressional Democrats seek leverage to add more policy riders.