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BioPharma Drug Approval

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

FDA Approves Utidelone Injectable (UTD1) Trial for Non-Small Cell Lung Cancer

Designated as BG01-2202, this trial is a multi-national, phase 2/3, open-label, randomized, controlled clinical study of utidelone injectable (UTD1) v...

June 16, 2023 | News

C2 PHARMA Receives Approval for Digoxin China DMF, Becoming China’s Only European Supplier of This API

C2 Pharma the global leader in manufacturing and supplying ophthalmic and niche active pharmaceutical ingredients (APIs), proudly announces the appro...

June 14, 2023 | News

InnoCan Pharma Submits New Patent Applications for Advanced Pain Relief Technology

InnoCan Pharma Corporation (CSE:INNO) ("Innocan Pharma" or the "Company"), a pharmaceutical technology company leveraging its novel cannabis-bas...

June 13, 2023 | News

Biosyngen's Cell Therapy BRG01 Receives FDA Orphan Drug Designation for Nasopharyngeal Cancer Treatment

The FDA Orphan Drug Designation program grants orphan status to promising investigation drugs or biological products designed to treat, prevent or diagnose...

June 07, 2023 | News

Guardant Health's Guardant360® CDx Blood Test Approved by Singapore Health Authority for Advanced Solid Cancers

Guardant360® CDx is a comprehensive genomic profiling blood test that provides critical information to help inform personalized treatment decisi...

May 31, 2023 | News

Bristol Myers Squibb receives positive CHMP opinion for Opdivo as neoadjuvant treatment for high-risk non-small cell lung cancer

If approved, Opdivo with chemotherapy would be the first and only neoadjuvant immunotherapy-based option authorized to treat patients with non-sm...

May 29, 2023 | Regulatory

Pfizer's PAXLOVID™ FDA-approved for high-risk adults with severe COVID-19

PAXLOVID is the first FDA-approved oral treatment for COVID-19; has been authorized for emergency use since December 2021 Approval is based on the total...

May 29, 2023 | News

Antengene's ATG-022 Receives Orphan Drug Designations for Gastric and Pancreatic Cancers

Orphan Drugs, also known as Rare Disease Drugs, refers to pharmaceutical products developed for the prevention, diagnosis, and treatment of rare diseases o...

May 24, 2023 | News

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