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 Danish firm’s injectable growth hormone analogue has succeeded in a late-stage study of children with a growth disorder and offers more convenient dosing that could improve adherence.
Opioids are cheap, but the economics of clinical practice, including the shift of care from inside the hospital to outpatient or ambulatory facilities, are creating new opportunities for Pacira BioSciences’ non-opioid treatments for pain. Improved reimbursement and increased usage among anesthesiologists are the biggest revenue drivers for the company’s two marketed products.
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.