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BioPharma Drug Approval

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

Antengene Clears U.S. IND for Phase I Trial of ATG-031 Antibody

- ATG-031, discovered and developed in-house by Antengene, is the world's first anti-CD24 antibody to advance to the clinic in oncolog...

May 18, 2023 | News

Antengene Announces NDA Submission for XPOVIO® in Indonesia

"In just six months, we have submitted NDAs for XPOVIO® in three ASEAN countries, Malaysia, Thailand and Indonesia, supporting...

May 17, 2023 | News

Innovent's IBI351 gets NMPA breakthrough designation for advanced colorectal carcinoma

This BTD for IBI351 was based on the pooled analysis of two ongoing clinical trials (NCT05005234, NCT05497336), which include 54 CRC pa...

May 15, 2023 | News

GenAssist's GEN6050 Base Editing Product Submits Pre-IND Application to FDA

Suzhou GenAssist Therapeutic Co.,Ltd recently announced its pre-IND application of their first base editing product, GEN6050 and the acceptance by the FDA....

May 08, 2023 | News

Formosa Pharmaceuticals and AimMax Therapeutics Submit NDA to US FDA for APP13007 for Post-Operative Pain and Inflammation after Ocular Surgery.

This proprietary homogeneous nanosuspension has a solution-like appearance which offers great comfort to the eyes and enhanced drug penetration into ocular...

May 05, 2023 | News

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

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

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

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

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

Antengene Clears U.S. IND for Phase I Trial of ATG-031 Antibody

Antengene Announces NDA Submission for XPOVIO® in Indonesia

Innovent's IBI351 gets NMPA breakthrough designation for advanced colorectal carcinoma

GenAssist's GEN6050 Base Editing Product Submits Pre-IND Application to FDA

Formosa Pharmaceuticals and AimMax Therapeutics Submit NDA to US FDA for APP13007 for Post-Operative Pain and Inflammation after Ocular Surgery.

FDA Approves First Respiratory Syncytial Virus (RSV) Vaccine

FDA Approves Teva and MedinCell's UZEDY™ for Adult Schizophrenia Treatment

RNAimmune's RV-1730 COVID-19 booster vaccine receives FDA clearance for Phase 1 trial.

Bridge Biotherapeutics Receives FDA Approval for First-in-Human Study of BBT-207, a 4th Gen EGFR TKI.

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