ArkBio Announces FDA Clearance to Initiate Phase II Trial of AK0406 for Influenza Prevention

ArkBio Announces FDA Clearance to Initiate Phase II Trial of AK0406 for Influenza Prevention

SHANGHAI, Oct. 13, 2026 /PRNewswire/ -- Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio") today announced that the U.S. Food and Drug Administration (FDA) has granted its investigational new drug (IND) application for AK0406, a long-acting...

World's First | Mabwell's 9MW5211 Receives FDA Clearance for Clinical Trial Application

World's First | Mabwell's 9MW5211 Receives FDA Clearance for Clinical Trial Application

SHANGHAI, May 9, 2026 /PRNewswire/ -- Mabwell (688062.SH, 02493.HK), an innovation-driven biopharmaceutical company with a fully integrated industry chain, announced that the Investigational New Drug (IND) application for 9MW5211, its independently...

YolTech Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for YOLT-101, an In Vivo Base Editing Therapy to Treat Heterozygous Familial Hypercholesterolemia (HeFH)

YolTech Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for YOLT-101, an In Vivo Base Editing Therapy to Treat Heterozygous Familial Hypercholesterolemia (HeFH)

SHANGHAI, June 6, 2025 /PRNewswire/ -- YolTech Therapeutics, a clinical-stage biotechnology company developing in vivo genome editing therapies, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company's...

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