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BioPharma Drug Approval

FDA 21 CFR Part 11: 7 Ways to Avoid Noncompliance

The FDA’s guidance for the creation and storage of electronic signatures and records as official documentation has held fast for 30 years. However,...

February 03, 2023 | News

FDA Approves First Oral Treatment for Anemia Caused by Chronic Kidney Disease for Adults on Dialysis

"With an oral drug option in addition to the FDA-approved injection options, adults with chronic kidney disease on dialysis now have multiple ways to treat...

February 02, 2023 | News

Lecanemab Receives Priority Review Status in Japan

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Chri...

January 30, 2023 | News

Alpha Biopharma Submits New Drug Application for Zorifertinib

Alpha Biopharma, a developer of innovative drugs, announces that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA...

January 30, 2023 | News

Dr. Reddy’s successfully completes full set of clinical studies of its rituximab biosimilar for filing in the U.S., Europe

Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; hereafter referred to as “Dr. Reddy’s”), a g...

January 23, 2023 | News

Henlius' Novel Anti-PD-1 mAb HANSIZHUANG (Serplulimab) Approved for the Treatment of ES-SCLC

World's first anti-PD-1 mAb for the first-line treatment of SCLC Making a new record with the median OS of 15.8 months in an international, mult...

January 18, 2023 | News

Isohelix Files US FDA Pre-Submission for GeneFix Saliva DNA Collectors

The GeneFix® Saliva DNA/RNA Collection devices are market leading and designed for the collection and preservation of DNA/RNA from saliva, pr...

January 11, 2023 | News

FDA approves LEQEMBI™ (lecanemab-irmb) under the Accelerated Approval pathway for the treatment of Alzheimer's disease

BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that under the Accelerated Approval pathway the U.S. Food and Drug...

January 09, 2023 | News

Burning Rock Received FDA Breakthrough Device Designation for its OverC™ Multi-Cancer Detection Blood Test

Under the FDA's Breakthrough Devices Program, the Breakthrough Device Designation is granted to certain medical devices that provide for more effective tre...

January 04, 2023 | News

Legend Biotech Announces Acceptance of Its New Drug Application for Ciltacabtagene Autoleucel (Cilta-Cel) in China

This submission is based on data from the confirmatory Phase 2 clinical study CARTIFAN-1 (NCT03758417) conducted in China, which evaluated the efficacy and...

January 03, 2023 | News

The Best of 2022: FDA Approvals and the Breakthroughs That Enabled Them

For a field like cancer research, in which progress can sometimes appear to happen slowly, it is especially important to remind ourselves of the crucial ad...

December 31, 2022 | News | By Calley Jones, PhD

Japan Ministry of Health, Labor and Welfare Approves Manufacturing and Marketing of Adtralza® (tralokinumab) in Japan for Adults with Atopic Dermatitis

Approval is a significant advancement for those patients in Japan who continue to suffer from the often-debilitating symptoms of atopic dermatitis and are ...

December 26, 2022 | News

Everest Medicines' Licensing Partner Pfizer Announces FDA and EMA Acceptance of Etrasimod Regulatory Submissions for Ulcerative Colitis

The European Medicines Agency (EMA) has also accepted the Marketing Authorization Application (MAA) for etrasimod in the same patient population with...

December 22, 2022 | News

Biocytogen Announces FDA Clearance of IND Application for Bispecific Antibody YH008

The trial is an open-label, dose-escalation study (No. YH008101) that will evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor a...

December 21, 2022 | News

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