Leads Biolabs Secures Priority Review for Opamtistomig
NANJING, China | July 10, 2026 Nanjing Leads Biolabs Co., Ltd. has announced that the Center for Drug Evaluation...
Priority Review
Advertisement
Genentech Wins FDA Priority Review for Enspryng in Thyroid Eye Disease
SOUTH SAN FRANCISCO, Calif., June 29, 2026 Genentech, a member of the Roche Group, announced that the U.S. Food...
Roche’s Giredestrant NDA Accepted by FDA for Early Breast Cancer
BASEL, Switzerland, June 2, 2026 Roche announced that the U.S. Food and Drug Administration (FDA) has accepted the New...
FDA Accepts Genentech NDA for Giredestrant in Early Breast Cancer
SOUTH SAN FRANCISCO, Calif., June 1, 2026 Genentech announced that the U.S. Food and Drug Administration (FDA) has accepted...
HUTCHMED Advances Sovleplenib NDA for wAIHA in China
HONG KONG, SHANGHAI & FLORHAM PARK, N.J., April 29, 2026 HUTCHMED (China) Limited has announced that the New Drug...
Advertisements
Daiichi Sankyo Secures FDA Priority Review for ADC Therapy
Tokyo, Japan & Basking Ridge, New Jersey | April 13, 2026 Daiichi Sankyo, in collaboration with Merck & Co.,...
HUTCHMED’s Savolitinib NDA Gains Priority Review in China
Hong Kong / Shanghai | December 30, 2025 — HUTCHMED announced that China’s drug regulator has accepted the New...
Immedica Submits NDS for Loargys® (pegzilarginase) in Canada
Stockholm, Sweden – October 31, 2025 — Immedica Pharma has announced that its New Drug Submission (NDS) for Loargys®...
FDA Accepts BioMarin’s PALYNZIQ sBLA for Priority Review in Adolescents with PKU
San Rafael, California — October 30, 2025 — BioMarin Pharmaceutical Inc. announced that the U.S. Food and Drug Administration...
FDA Issues Complete Response Letter for SL1009 in PDCD Treatment
ROSWELL, Ga., September 8, 2025 — Saol Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has...
Advertisement
