FDA News
FDA Approves Enhertu for HER2-Positive Early-Stage Breast Cancer
FDA approves Enhertu (fam-trastuzumab deruxtecan-nxki) for early-stage HER2-positive breast cancer in a neoadjuvant ...
JULY 10, 2026
Decnupaz Approved for Blastic Plasmacytoid Dendritic Cell Neoplasms
Pivekimab sunirine-pvzy approved for blastic plasmacytoid dendritic cell neoplasm, offering a new targeted ...
JULY 7, 2026
Tecentriq Approved for Muscle-Invasive Bladder Cancer
FDA approves atezolizumab and Tecentriq Hybreza for ctDNA MRD-positive muscle-invasive bladder cancer after ...
JULY 5, 2026
FDA Approves Bizengri for NRG1 Fusion–Positive Cholangiocarcinoma
FDA approves Bizengri for NRG1 fusion–positive cholangiocarcinoma, offering new hope for patients with this ...
JUNE 26, 2026
FDA Approves Inqovi With Venetoclax for AML
FDA approves decitabine and cedazuridine plus venetoclax for newly diagnosed AML in older adults, offering an ...
MAY 23, 2026
FDA Approves Veppanu for Some Forms of Advanced Breast Cancer
FDA approves Veppanu for ER-positive, HER2-negative, ESR1-mutated advanced breast cancer, offering a new oral ...
MAY 10, 2026
Opdivo With Chemotherapy Approved for Previously Untreated Hodgkin Lymphoma
The FDA has approved nivolumab (Opdivo, Bristol Myers Squibb), in combination with AVD (doxorubicin, vinblastine, ...
APRIL 9, 2026
Keytruda With Paclitaxel Approved for Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma
Drug combination approved for certain adult patients with platinum-resistant epithelial ovarian, fallopian tube, or ...
FEBRUARY 12, 2026
FDA Approves Darzalex Faspro With VRd for Newly Diagnosed Multiple Myeloma
The FDA approved Darzalex in combination with VRd for adults with newly diagnosed multiple myeloma who are ...
JANUARY 29, 2026
FDA Grants First Priority Voucher Approval to Augmentin XR
FDA approved Augmentin XR to be manufactured by USAntibiotics under its new CNPV program, intending to boost U.S. ...
JANUARY 9, 2026
FDA Grants Regular Approval to Rubraca for Metastatic Castration-Resistant Prostate Cancer
The FDA approved Rubraca for adults with certain metastatic castration-resistant prostate cancer.
DECEMBER 31, 2025
FDA Approves Rybrevant Faspro for Subcutaneous Injection
The FDA approved Rybrevant Faspro for subcutaneous injection for adult patients across all indications approved for ...
DECEMBER 31, 2025