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Gadopiclenol Marketing Authorization Dossier Submissions Accepted for Review by EMA and FDA

Guerbet , a global leader in medical imaging offering a comprehensive range of pharmaceutical products, medical devices, and digital and artificial intelligence (AI) solutions...

Novartis Pluvicto Approved by FDA as First Targeted Radioligand Therapy

Novartis announced today that the US Food and Drug Administration (FDA) approved Pluvicto™ (lutetium Lu 177 vipivotide tetraxetan) (formerly referred to as 177Lu-PSMA-617) for...

Dialectic Therapeutics Announces DT2216 Has Received Orphan Drug Designation from the FDA for the Treatment of T-Cell Lymphoma

Dialectic Therapeutics, Inc., a Texas-based clinical stage biotechnology company focused on creating innovative new technologies to treat cancer, announced that the U.S. Food and...

Specialty Enzymes & Probiotics is Proud to Announce That the FDA has Granted GRAS No Objection Letter for SEBclausii

The GRAS Notification Program is a voluntary submission for products intended as food additives. Based on our extensive research, specifications, intended usage, history, preparation,...

FDA Makes Low-Risk Determination for Marketing of Products from Genome-Edited Beef Cattle After Safety Review

The U.S. Food and Drug Administration announced it has made a low-risk determination for the marketing of products, including food, from two genome-edited beef...
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