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Conducting Clinical Trials amid the COVID-19 Outbreak: FDA Encourages Sponsors to Go Virtual Neeta Ratanghayra
April 08, 2020
For pharmaceutical companies, one of the most significant operational impacts of the COVID-19 is on clinical trials. On March 19, 2020, the U.S. Food and Drug Administration (FDA) issued guidance on the conduct of clinical trials during the COVID-19 pande
Henlius Receives Orphan Drug Designation for HLX22 in the U.S. for Gastric Cancer PR Newswire
March 19, 2025
Henlius announced that FDA has granted ODD for HLX22, the company's innovative anti-HER2 mAb for the treatment of gastric cancer.
Henlius Receives Orphan Drug Designation for Innovative Anti-HER2 mAb HLX22 in the U.S. for Gastric Cancer PR Newswire
March 19, 2025
Shanghai Henlius Biotech announced that FDA has granted ODD for HLX22 for the treatment of gastric cancer.
Innovent Receives Second Fast Track Designation from the U.S. FDA for IBI363 in Squamous Non-Small Cell Lung Cancer PR Newswire
February 17, 2025
Innovent Receives FDA for IBI363 in Squamous Non-Small Cell Lung Cancer
Navi Medical Technologies' Neonav® ECG Tip Location System Receives FDA 510(k) Clearance PR Newswire
February 17, 2025
FDA 510(k) Clearance Revolutionising Vascular Access Care for Critically Ill Newborns and Children
FDA Clears World's First Mobile App for Contactless Pulse Rate Measurement PharmaSources
January 26, 2025
On Jan. 26, Hong Kong - based PanopticAI announced getting FDA 510(k) clearance for its contactless vital signs monitoring software, turning mobile devices into medical - grade monitors.
Telix Files TLX250-CDx (Zircaix®) BLA for Kidney Cancer Imaging PRNewswire
December 30, 2024
Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals and associated medical technologies.
Thrombolytic Science Announces FDA’s IND Clearance of Mutant Prourokinase for the Treatment of Thrombotic Diseases PharmaSources
October 15, 2024
Thrombolytic Science, LLC (TSI), announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for mutant prourokinase, a recombinant fibrinolytic pro-enzyme.
The Narrative of Pharmaceuticals Bestowed with Endorsement and Later Reclaimed by Oblivion by the FDA zhulikou431
March 06, 2024
This document endeavors to compile and elucidate data pertaining to instances where the U.S. FDA, in recent years, has rescinded market approval for pharmaceuticals previously sanctioned.
Polpharma Biologics Announces FDA Approval of Tyruko® - First And Only Approved Biosimilar to Tysabri®* for Relapsing Forms of Multiple Sclerosis PharmaSources
August 28, 2023
On August 25, 2023,Polpharma Biologics announced today that the U.S. Food and Drug Administration (FDA) is the first regulatory body worldwide to approve the use of Tyruko®.

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