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Complete Response Letter
Pharma
FDA's CNPV speedy review program, CRL disclosures go quiet
Both the Commissioner’s National Priority Voucher pilot and the FDA’s real-time release of complete response letters have faced legal scrutiny.
Angus Liu
Nov 12, 2026 11:26am
Xspray's Dasynoc knocked back by FDA over production once again
Aug 20, 2026 2:50pm
ITM cancer drug spurned by FDA over manufacturing qualms
Aug 10, 2026 11:25am
Novo’s Catalent plant ditched in FDA refiling of SMA drug
Aug 10, 2026 10:06am
2 FDA citations trouble Hengrui, Elevar’s liver cancer combo
Jul 28, 2026 3:02pm
After 3 CRLs, FDA approves Outlook's AMD drug Lytenava
Jul 27, 2026 11:51am
