FDA approves HERNEXEOS(R), the first targeted therapy for adults with HER2-mutant advanced NSCLC as an initial treatment option

The FDA granted zongertinib Breakthrough Therapy Designation for patients with HER2 (ERBB2)-mutant advanced NSCLC as an initial treatment. The FDA also awarded a Commissioner's National Priority ...

FDA approves Dupixent for allergic fungal rhinosinusitis

The U.S. Food and Drug Administration has approved Dupixent (dupilumab) for the treatment of adult and pediatric patients ...
TheHour

FDA to offer bonus payments to staffers who complete speedy drug reviews

The head of the Food and Drug Administration plans to start offering bonus payments to agency drug reviewers who complete their work ahead of the schedule. The pilot program was announced ...
Healio

FDA accepts supplemental NDA for phentolamine in presbyopia

The FDA accepted a supplemental new drug application to expand the indication for Ryzumvi to include the treatment of ...

FDA approves HERNEXEOS®, the first targeted therapy for adults with HER2-mutant advanced NSCLC as an initial treatment option

HERNEXEOS product image Product image This press release is not intended for UK media HERNEXEOS® (zongertinib tablets) ...
STAT

Rare disease advocates fume over FDA’s mixed signals

Her son Ben, she learned, had mucopolysaccharidosis (MPS) type 2, or Hunter Syndrome, one of a group of rare diseases that is ...