FDA News
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
FDA Approves Cardamyst Spray for PSVT
The FDA approved Cardamyst nasal spray for episodes of paroxysmal supraventricular tachycardia in adults.
DECEMBER 18, 2025
FDA Grants New Indication for Blujepa: Uncomplicated Gonorrhea
The FDA has approved gepotidacin for the treatment of uncomplicated urogenital gonorrhea caused by susceptible ...
DECEMBER 15, 2025
Oral Nuzolvence Approved for Uncomplicated Gonorrhea
FDA approves new oral antibiotic addressing resistant Neisseria gonorrhoeae.
DECEMBER 12, 2025
FDA Grants Traditional Approval to Imdelltra for Extensive-Stage SCLC
The FDA granted traditional approval to Imdelltra for adults with extensive-stage small cell lung cancer with ...
DECEMBER 4, 2025
FDA Grants Accelerated Approval to Hyrnuo for Nonsquamous NSCLC
The FDA granted accelerated approval to Hyrnuo for some adults with locally advanced or metastatic nonsquamous ...
DECEMBER 3, 2025
FDA Approves Contepo for cUTIs
The FDA has approved fosfomycin for injection (Contepo, Meitheal) for the treatment of complicated urinary tract ...
NOVEMBER 4, 2025