The FDA decision is anticipated by 18 December 2026.

Bristol Myers Squibb BMY announced that the FDA has accepted the new drug application (NDA) for its pipeline candidate, iberdomide, in combination with standard therapies (daratumumab and ...

NDA is supported by positive data from two Phase 3 studies and a long-term extension study, demonstrating sustained reduction in heavy menstrual bleeding while maintaining bone health through one year ...

ROCKVILLE, Md. and SUZHOU, China, April 2, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and ...

HUTCHMED (China) Limited and Innovent Biologics, Inc. have announced that their New Drug Application (NDA) for the combination therapy of fruquintinib and sintilimab for treating advanced renal cell ...

(RTTNews) - Exelixis, Inc. (EXEL) announced that its New Drug Application for zanzalintinib, in combination with atezolizumab, has been accepted for review in the U.S. for the treatment of adult ...

SAN FRANCISCO and SUZHOU, China, Feb. 23, 2025 /PRNewswire/ — Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and ...

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., June 05, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; HKEX: 13) and Innovent Biologics, Inc. (“Innovent”) (HKEX: ...

SAN FRANCISCO and SUZHOU, China, June 4, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and ...

The NDA is supported by data from FRUSICA-2, a randomized, open-label, active-controlled registration study evaluating the efficacy and safety of fruquintinib in combination with sintilimab versus ...