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Federal Register notice: FDA announces a 10/16 public meeting entitled Advancing Rare Disease Therapies Through an FDA Rare Diseas...[ Price : $8.95]
Federal Register notice: FDA withdraws an 8/2 notice that sought comments on a proposed information collection entitled Risk/Safet...[ Price : $8.95]
After receiving a complete response letter, Lykos Therapeutics says it will pursue FDAs dispute resolution process to question the...[ Price : $8.95]
FDA approves an Ascendis Pharma NDA for Yorvipath (palopegteriparatide) for treating hypoparathyroidism in adults.[ Price : $8.95]
FDA tells Humacyte it needs more time to complete the review of BLA for the acellular tissue-engineered vessel, indicated for trea...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Optimizing the Dosage of Human Prescription Drugs and Biolo...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Bacillus Calmette-Gurin-Unresponsive Nonmuscle Invasive Bla...[ Price : $8.95]
FDA lifts a clinical hold against 4D Molecular Therapeutics 4D-310 therapy being studied for treating Fabry disease cardiomyopathy...