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BioPharma Drug Approval

FDA Accepts Supplemental Biologics License Application (sBLA) for KEYTRUDA® (pembrolizumab)

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted for...

April 17, 2023 | News

Minghui Pharma's MH004 Cream Succeeds in Phase 2 Trial for Atopic Dermatitis, Global Phase 3 MRCT Cleared by FDA

Study met both primary and all key secondary endpoints Mean percentage change from baseline in Eczema Area and Severity Index (EASI) score was -78.7% in...

April 14, 2023 | News

Biosyngen received China NMPA IND approval for its T-cell redirection therapy targeting EBV-positive Lymphoma

Currently, commercially available cell therapies, such as CD19 CAR-T, are designed for the treatment of B cell lymphoma or acute lymphoblastic leukemia. Tr...

April 12, 2023 | News

Boan Biotech's Biologics License Application for Boyounuo® (Bevacizumab Injection) Accepted in Brazil

Envisioned to be "a leading global biopharmaceutical company", Boan Biotech develops biologics for both Chinese and international markets, including E...

April 12, 2023 | News

JW Therapeutics' Relma-cel approved for systemic lupus erythematosus trial.

SLE is a complex autoimmune disease with diverse clinical manifestations involving many organs and systems. It is estimated that China has 1 mill...

April 11, 2023 | News

Chinese NMPA Approves Study of Telix Brain Cancer Therapy Candidate

The investigational new drug (IND) application was submitted by Telix's partner in the Greater China region, Grand Pharmaceutical Group Limited (...

April 11, 2023 | News

Tillotts Pharma AG announces the launch of Octasa® 1600 mg tablets in Canada

The expansion of the Octasa® family in Canada with the launch of Octasa® 1600 mg represents an important step in the strategic partnership of Tillo...

April 07, 2023 | News

Leica Biosystems Strengthens Portfolio with FDA Clearance of Class II Mismatch Repair (MMR) Panel

Leica Biosystems announced the US Food and Drug Administration (FDA) 510(k) clearance of the BOND MMR Antibody Panel, providing customers with a high-perfo...

April 04, 2023 | News

ImmVira's MVR-C5252 for Malignant Glioma Approved for Clinical Trial in China

In July 2022, the Company entered into a cooperative agreement with China Resource Biopharma ("CRBio") to jointly develop MVR-C5252 in the Greate...

March 30, 2023 | Regulatory

Athos Therapeutics Receives Regulatory Approval to Commence Phase I Clinical Trial of ATH-063

Athos Therapeutics, Inc. ("Athos"), a clinical stage biotechnology company pioneering the development of artificial intelligence-based precision small mole...

March 30, 2023 | Regulatory

Indian Immunologicals Limited receives regulatory approval for Measles-Rubella (MR) Vaccine

Indian Immunologicals Limited (IIL), a leading vaccine manufacturer has announced receipt of approval from Drugs Controller General of India and State...

March 28, 2023 | News

Biogen Provides Update on FDA Advisory Committee Meeting on Tofersen for SOD1-ALS

Biogen Inc. (Nasdaq: BIIB) announced today the outcome of the U.S. Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Dr...

March 23, 2023 | News

Aquavit Files Two IND's For Its Botulinum Toxin With FDA

Aquavit Holdings, the exclusive licensee of Huons Global's Botulinum Toxin in the USA and Canada, will officially unveil the Aquatox™ ...

March 18, 2023 | Regulatory

Glenmark's GRC 54276 IND application accepted by US FDA for first-in-human study on advanced tumors

Glenmark Specialty SA, the subsidiary of Glenmark Pharmaceuticals Ltd., an innovation-driven, global pharmaceuticals company received acceptance from the U...

March 17, 2023 | News

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