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Drug Approval

New technology designed to help inform real-time clinical decisions during kidney stone procedures

Boston Scientific Corporation (NYSE: BSX) today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the LithoVue™ Elite Single...

February 06, 2023 | News

Regulatory filing for house dust mite allergy tablet accepted for review in China

The BLA, for treatment of persistent moderate-to-severe HDM allergic rhinitis in patients aged 12–65 was submitted in late December 2022. S&...

February 03, 2023 | News

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

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