The FDA granted Moderna’s RSV vaccine candidate Breakthrough Therapy Designation Monday.
Tag Archive for: Breathrough Therapy Designation
AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu has been approved by the U.S. Food and Drug Administration as the first HER2-directed medicine for patients with HER2-mutant metastatic NSCLC, a particularly lethal form of the disease.
The U.S. Food and Drug Administration released new draft guidance that addresses Breakthrough Therapy designation.
Vertex Pharmaceuticals announced on Wednesday that the U.S. Food and Drug Administration granted Breakthrough Therapy Designation to the company’s candidate, inaxaplin (VX-147). Inaxaplin was granted the designation for the treatment of APOL1-mediated focal segment glomerulosclerosis (FSGS).
