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Latest From Mallinckrodt plc
The merger closed in May, so the second quarter earnings report will be the first presentation of the combined company’s performance and outlook.
The first virtual US FDA advisory committee review of a drug application was nearly a disaster, but the second proved that the concept can work. Nevertheless, things are going to be very different for sponsors, even when the technology is perfected.
Mallinckrodt’s Terlipressin Narrowly Clears US FDA Panel As Need For Liver Treatment Outweighs Safety Worries
Advisory committee votes 8-7 to recommend approval for terlipressin to treat HRS-1 but is critical of Mallinckrodt’s plan to mitigate the risk of respiratory failure.
Benefits of the BCMA-directed antibody-drug conjugate outweigh its ocular risks in heavily pretreated multiple myeloma patients, Oncologic Drugs Advisory Committee says at the conclusion of a virtual meeting beset by technical problems.
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