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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.
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®.
FDA Inspections of Outsourcing Facilities FDA
March 31, 2022
Provide an overview of the inspection process for compounding outsourcing facilities.
Immunogenicity Information in Labeling FDA
March 25, 2022
This webinar has been approved for 1.5 contact hours of continuing education for pharmacists, physicians, and nurses. Please see detailed announcement for additional information.
FDA Approves First Generic of Symbicort to Treat Asthma and COPD FDA
March 17, 2022
Today, the U.S. Food and Drug Administration approved the first generic of Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol for the treatment of two common pulmonary health conditions...

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