BioPharma Drug Approval
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
Pulmonx Receives Japanese MHLW Approval of Zephyr Endobronchial Valve for the Treatment of Severe COPD/Emphysema
Pulmonx Corporation (Nasdaq: LUNG) (“Pulmonx”), a global leader in minimally invasive treatments for severe lung disease, announced today that ...
December 02, 2022 | News
Everest Medicines Announces Major Regulatory Updates in Taiwan and South Korea
-- Taiwan Food and Drug Administration grants Accelerated Approval Designation (AAD) to Nefecon -- -- Ministry of Food and Drug Safety in S...
November 28, 2022 | News
Hugel's 'Letybo' First in Korea to Obtain Marketing Approval from Australia
Obtained marketing approval on the 23rd (local time) from the Therapeutic Goods Administration (TGA) of Australia for the indication of gl...
November 25, 2022 | News
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