Federal Register notice: FDA announces a 9/13 advisory committee meeting to discuss an Intercept Pharmaceuticals supplemental NDA for Ocaliva (obetich...
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...
FDA approves an ARS Pharmaceuticals NDA for neffy (epinephrine nasal spray) for the emergency treatment of allergic reactions.
Braun Medical recalls (Class 1) two lots of 0.9% sodium chloride for injection USP 1,000 mL due to the potential for particulate matter in the drug co...
