Johnson & Johnson files a BLA for nipocalimab, indicated for treating people living with generalized myasthenia gravis.
FDA publishes two revised Veterinary International Conference on Harmonization guidances on validation of analytical procedures for veterinary drugs.
FDA clears a Think Surgical 510(k) for the TMini Miniature Robotic System and its use with the GMK Sphere and SpheriKA Knee Systems from Medacta Inter...
Merck says that on the recommendation of independent data monitoring committees, it is discontinuing a Keytruda lung cancer trial and a cutaneous squa...
Tandem Diabetes Care says it is recalling an Apple app used with its t:slim insulin pump and replacing it with updated software.
CDER creates a new internal Artificial Intelligence Council to oversee, coordinate, and consolidate all Center AI activities.
FDA grants Nuvectis Pharma an orphan drug designation for NXP800 and its use in treating ovarian, fallopian tube, and primary peritoneal cancers.
FDA approves a Renata Medical PMA for its Minima Growth Stent thats intended for treating congenital heart disease in infants and young children.
