FDA grants accelerated approval to asciminib for newly diagnosed chronic myeloid leukaemia
On October 29, 2024, the Food and Drug Administration granted accelerated approval to asciminib (Scemblix,…
Browsing: FDA Approvals
FDA approves zolbetuximab-clzb with chemotherapy for gastric or gastroesophageal junction adenocarcinoma
Tthe Food and Drug Administration have approved zolbetuximab-clzb, a claudin 18.2 (CLDN18.2)-directed cytolytic antibody, with…
FDA approves neoadjuvant/adjuvant nivolumab for resectable non-small cell lung cancer
On October 3, 2024, the Food and Drug Administration approved nivolumab (Opdivo, Bristol Myers Squibb…
FDA approves amivantamab-vmjw with carboplatin and pemetrexed for non-small cell lung cancer with EGFR exon 19 deletions or L858R mutations
On September 19, 2024, the Food and Drug Administration approved amivantamab-vmjw with carboplatin and pemetrexed…
FDA approves selpercatinib for RET fusion-positive medullary thyroid cancer
On September 27, 2024, the Food and Drug Administration granted traditional approval to selpercatinib for…
FDA approves isatuximab-irfc with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma
On September 20, 2024, the Food and Drug Administration approved isatuximab-irfc (Sarclisa, Sanofi-Aventis U.S. LLC)…
FDA approves lazertinib with amivantamab-vmjw for non-small lung cancer
On August 19, 2024, the Food and Drug Administration approved lazertinib (Lazcluze, Janssen Biotech, Inc.)…
FDA approves new therapy for glioma patients for first time in decades
Vorasidenib has been approved by the U.S. Food and Drug Administration (FDA) for patients with…
FDA approves blood test as a primary screening option for colorectal cancer
Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, has announced that the U.S.…
FDA approves vorasidenib
A new drug for treatment of a type of brain cancer, called IDH-mutant low-grade glioma,…