BioPharma Drug Approval
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
CStone Receives China NMPA Approval for GAVRETO® in First-Line Treatment of RET Fusion-Positive Lung Cancer.
The approval for the first-line treatment of RET fusion-positive non-small cell lung cancer marks the third indication of GAVRETO in Mainland Chi...
June 27, 2023 | News
Pfizer’s TALZENNA® in Combination with XTANDI® Receives U.S. FDA Approval
Pfizer (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has approved TALZENNA (talazoparib), an oral poly ADP-ribose polymerase...
June 21, 2023 | News
Sirnaomics Advances STP705 for SCCIS into Late-Stage Clinical Development
The FDA provided Sirnaomics guidance to move forward with late-stage clinical development because of the efficacious data provided as well as the widesprea...
June 20, 2023 | News
SK bioscience COVID-19 Vaccine Granted Emergency Use Listing by the World Health Organization
In a Phase III trial, the vaccine demonstrated neutralizing antibody responses against SARS-CoV-2 parental strain and had a standard safety and reactogen...
June 19, 2023 | News
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