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Federal Register notice: FDA makes available a draft guidance entitled Bacillus Calmette-Gurin-Unresponsive Nonmuscle Invasive Bladder Cancer: Develop...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