BioPharma Drug Approval
CanariaBio's MAb-AR20.5 for Pancreatic Cancer Granted FDA Orphan Drug Designation
CanariaBio Inc., a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative immunotherapies for cancer, anno...
August 22, 2023 | News
Everest Medicines' Partner Calliditas Therapeutics Gets FDA Priority Review for Nefecon® in IgA Nephropathy
"We congratulate our partner Calliditas for being granted priority review by the FDA for full approval and taking a step closer to offering this first-in-d...
August 22, 2023 | Regulatory
Innovent's SINTBILO® Receives NMPA Approval for Treating Hypercholesterolemia
The prevalence of cardiovascular diseases is continuously increasing in China, among which atherosclerotic cardiovascular disease (ASCVD) is the leadi...
August 17, 2023 | News
FDA Grants Priority Review for Cefepime-Taniborbactam to Treat cUTI
Everest Medicines (HKEX 1952.HK)'s partner Venatorx Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has accepted the company's N...
August 16, 2023 | News
Ascentage Pharma Gets FDA Clearance for Global Phase III Trial of Lisaftoclax in CLL/SLL Patients
Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, chronic hepatitis B (CHB), and age-related...
August 07, 2023 | News
US FDA Grants Orphan Drug Status to ABM-1310 for BRAF V600 Glioblastoma
Orphan Drug Designation is a significant recognition bestowed by the FDA to the drugs used in the treatment of rare diseases. This designation intends to e...
August 03, 2023 | News
Doer Biologics Initiates Phase I MAD Trial of DR10624, Receives NMPA IND Approval
The Phase I MAD study is a randomized, placebo-controlled, double-blind study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics ...
August 02, 2023 | News
NMPA and FDA Approve First-in-Human Trial for LBL-034 in Multiple Myeloma
This is a first-in-human, single-arm, multicenter, open-label, dose-escalation and expansion clinical study, and plans to enroll patients with relapsed/ref...
August 01, 2023 | News
Transcenta's Anti-sclerostin Antibody TST002 Approved for Phase II Trial in China for Reduced Bone Density Patients
This study aims to evaluate the safety, tolerability, and pharmacokinetics of TST002(Blosozumab) after single and multiple intravenous administrations in p...
July 31, 2023 | News
China's Mabwell Announces NMPA Approval of Novel B7-H3 ADC (7MW3711) for IND
B7-H3 is a member of the B7 ligand family and is overexpressed in most cancer types but expressed at a low level in normal tissues. In malignant tissues, B...
July 24, 2023 | News
South Korea's GC Biopharma's 'GC FLU' Vaccine Approved in Egypt
Striving to further expand its territory to Africa and the Middle East from Southeast Asia and Latin America "Will cr...
July 24, 2023 | News
US FDA Grants Orphan Drug Designation to SN Bioscience's 'SNB-101' for Small Cell Lung Cancer
SNB-101 showed excellent efficacy in animal small cell lung cancer models, and based on this, it has been designated as an orphan drug by the US FDA after ...
July 21, 2023 | News
Mabwell Announces the NMPA Approval of Novel Trop-2 ADC (9MW2921) for IND
9MW2921 is a next generation antibody-drug conjugate (ADC) developed by Mabwell based on IDDC™ (Interchain-Disulfide Drug Conjugate) platef...
July 19, 2023 | News
Antengene's XPOVIO® Approved in Hong Kong for Relapsed Multiple Myeloma
XPOVIO® has received regulatory approvals in 41 countries and regions including the United States, Israel, the United Kingdo...
July 17, 2023 | News
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