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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]
FDA approves an ARS Pharmaceuticals NDA for neffy (epinephrine nasal spray) for the emergency treatment of allergic reactions.[ Price : $8.95]
Braun Medical recalls (Class 1) two lots of 0.9% sodium chloride for injection USP 1,000 mL due to the potential for particulate m...[ Price : $8.95]
FDA selects American College of Cardiology chief innovation officer Ami Bhatt to serve a four-year term as chair of the agencys re...