BioPharma Drug Approval

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

FDA Approves First Gene Therapy for the Treatment of High-Risk, Non-Muscle-Invasive Bladder Cancer

"This approval provides healthcare professionals with an innovative treatment option for patients with high-risk non-muscle invasive bladder cancer that is...

 December 19, 2022 | News

Janssen Submits Biologics License Application to U.S. FDA

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a Biologics License Application (BLA) to the U.S. Food and ...

 December 12, 2022 | News

Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine in Children Under 5 Years

Bivalent vaccine authorized as third 3-µg dose in the three-dose primary series Consistent COVID-19 hospitalization rates in this age group couple...

 December 08, 2022 | News

FDA grants ODD for new NK treatment

The US FDA has granted Orphan Drug Designation (ODD) for BRM424 in the treatment of neurotrophic keratitis (NK), a rare degenerative eye diseas...

 December 08, 2022 | News


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