Keeping Track: Gavreto, Sogroya Bring Annual CDER Novel Approvals To 40; New Analgesic Products Make It Past US FDA
The latest drug approval news and highlights from the Pink Sheet’s US FDA Performance Tracker.
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The developers of eleven new drugs could learn this week whether the European Medicines Agency will set them on course for pan-EU marketing approval.
The Celgene acquisition gave BMS a new top-selling drug but Revlimid revenue will start to decline as soon as next year and it is likely to take many new products to replace it.
Avenue’s two-stage deal with an arm of Cipla faces uncertainty following a US Complete Response Letter for its intravenous tramadol. The US firm says it is "very surprised" with the potential safety concern raised and plans to seek a meeting with the agency at the earliest to resolve the issue.