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Drug Approval

Japan Approves Neurolief's Relivion®, Paving the Way for At-Home Migraine Treatment.

Relivion® is a novel, non-invasive multi-channel brain neuromodulation technology. It stands out by concurrently stimulating the occipital and tri...

January 12, 2024 | News

OBI Pharma's partner Biosion announces FDA clearance for the Phase 1/2 study of OBI-992 (TROP2 ADC)

First clinical trial to evaluate the safety and efficacy of OBI-992 (a.k.a BSI-992), a novel antibody drug conjugate (ADC) targeting TROP2 - Dosing of f...

January 09, 2024 | News

Caliway's CBL-514 IND for Dercum's Disease Phase 2 Study Accepted by FDA

Dercum's disease is a rare disease characterized by the growth of painful lipomas. The pain can be severe, chronic (> 3 months) and often disabling. So ...

January 09, 2024 | News

Akeso's Cadonilimab Granted NMPA Acceptance for First-Line Gastric Cancer Treatment.

This will be the second indication for which cadonilimab has received approval in China, following its use as a monotherapy treatment for recurrent or...

January 08, 2024 | News

EMA Validates Bristol Myers Squibb’s Repotrectinib Application for ROS1-Positive Lung Cancer

-Bristol Myers Squibb (NYSE: BMY) announced that the European Medicines Agency (EMA) has validated its marketing authorization application for t...

January 03, 2024 | News

Mundipharma Greenlights European Approval for REZZAYO® in Treating Adult Invasive Candidiasis

The approval is based on the positive results of the pivotal Phase III ReSTORE clinical trial and is supported by STRIVE's Phase II clinical trials and a...

January 01, 2024 | News

Breakthroughs Unveiled: A Year of Groundbreaking Novel Drug Approvals in 2023

Innovative drugs often mean new treatment options for patients and advances in health care for the American public. When it comes the development of new dr...

December 29, 2023 | News

FDA Grants Orphan Drug Designation to Boan Biotech's Two Novel Claudin 18.2 Drugs.

Orphan drugs, also known as drugs for rare diseases, are drugs for preventing, treating or diagnosing rare diseases. Being designated as orphan drugs will ...

December 28, 2023 | News

NMPA Accepts Mabwell's 8MW0511 Injection New Drug Application

8MW0511, a Class 1 therapeutic biological product, is a new generation of long-acting G-CSF (modified cytokine with high activity) with independent intelle...

December 20, 2023 | News

GC Biopharma's ALYGLO™ 10% Liquid FDA Approved for Adult Primary Immunodeficiency.

The ALYGLO pivotal phase 3 clinical study followed FDA guidance for the treatment of patients with PI. The clinical trial (NCT02783482) GC5107B was a prosp...

December 18, 2023 | News

Takeda Gets Positive CHMP Opinion for HYQVIA® in CIDP Maintenance Therapy

If Approved, HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] Would Offer an up to Once-Monthly Facilitated Subcut...

December 15, 2023 | News

Vertex Gets Positive CHMP Opinion for First CRISPR Gene Therapy, CASGEVY™, for Sickle Cell Disease

- If approved by the European Commission, patients 12 years of age and older with severe sickle cell disease or transfusion-dependent beta thal...

December 15, 2023 | News

CStone's Sugemalimab Granted NMPA Approval for Esophageal Cancer

Sugemalimab is the world's first anti-PD-L1 monoclonal antibody approved for use in combination with fluorouracil and platinum-based chemotherapy...

December 11, 2023 | News

FDA Prioritizes Review of PADCEV® Combo for Advanced Bladder Cancer

Results of pivotal confirmatory trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall survival and progres...

December 04, 2023 | News

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