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BioPharma Drug Approval

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

Biosyngen's First-in-class Cell Therapy BRG01 Receives FDA Fast Track Designation

Fast Track Designation (FTD) aims to facilitate the development of drugs targeting severe or life-threatening diseases that have the potential to a...

July 12, 2023 | News

280 Bio receives IND approval from the FDA for YL-17231

80Bio, Inc. a clinical stage biotechnology company focused on the development of precision oncology medicines, today announced that the U.S. Food and Drug ...

July 10, 2023 | News

Transcenta Receives Approvals for Global Phase III Trial of Osemitamab (TST001)

To initiate TranStar 301 global Phase III pivotal trial of Osemitamab (TST001) in combination with Nivolumab and chemotherapy for the first-line treatment ...

July 10, 2023 | News

Hexvix® Completes Phase III Bridging Trial Enrollment for Bladder Cancer

The study is a prospective, self-controlled, multicenter Phase Ⅲ trial aimed at investigating the additional detection rate and safety of Hexvix®&nbs...

July 10, 2023 | News

China NMPA approves RareStone's pitolisant (Wakix) for the treatment of narcolepsy

RareStone Group, a rare disease-focused company aiming to establish the first rare disease ecosystem in China, announced that on June 30, the Chi...

July 05, 2023 | News

FDA Approves Cu-64 SAR-bisPSMA Phase III Trial for Prostate Cancer

FDA agreement for a pivotal Phase III trial for 64Cu SAR-bisPSMA diagnostic in prostate cancer Phase III trial design based on&n...

July 05, 2023 | News

Jacobio Receives CDE Approval for Glecirasib's Pancreatic Cancer Pivotal Study in China

The pivotal clinical trial approved in China will evaluate the efficacy and safety of Glecirasib as a single agent for the second line treatment ...

July 05, 2023 | News

Innovent and IASO Bio Receive NMPA Approval for FUCASO®, a Fully-human BCMA CAR-T Therapy for Multiple Myeloma

Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality me...

July 03, 2023 | News

Cresilon Receives First FDA Clearance For Human Use of Hemostatic Gel Technology

This marks Cresilon's first FDA clearance for human use, validating its revolutionary hemostatic gel technology and the company's global mission to transfo...

June 30, 2023 | News

Harbour BioMed's Batoclimab Receives NMPA Acceptance for Generalized Myasthenia Gravis Treatment

"Anti-FcRn treatment is at the center of focus in gMG disease area. Batoclimab is the first anti-FcRn treatment completed clinical development with po...

June 30, 2023 | News

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