FDA grants Bayer a priority review for its supplemental NDA for Hyrnuo (sevabertinib) as a first-line treatment for patients with HER2-mutant non-small cell lung cancer.
Animal Drugs
Open Letter to Trump Urges FDA Push on Rare Diseases
In an opern letter to president Trump, rare disease advocates urge him to push FDA to accelerate approvals for treatments targeting fatal genetic disorders, arguing that regulatory delays are costing patients valuable time.
