This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.

As it navigates product transition in ophthalmology against biosimilar and branded rivals, Regeneron seems to have a simpler challenge in another major therapeutic area.

Nucala finally succeeds in a COPD Phase III study by narrowing its target patients, setting it up to compete in a huge new market to be led by Sanofi’s Dupixent.

Half of the FDA’s upcoming 2024 user fee goals target rare diseases, but highly prevalent conditions like uncomplicated urinary tract infections and atopic dermatitis are also up for agency action in the second half of the year.