FDA approves epcoritamab-bysp for follicular lymphoma indications
On November 18, 2025, the Food and Drug Administration approved epcoritamab-bysp with lenalidomide and rituximab for…
Browsing: FDA Approvals
Much-needed new drug approved for acute myeloid leukaemia
Biomedical research that began at the University of Virginia School of Medicine, USA, has yielded…
FDA approves imlunestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer
On September 25, 2025, the Food and Drug Administration approved imlunestrant, an oestrogen receptor antagonist,…
FDA approves pembrolizumab and berahyaluronidase alfa-pmph for subcutaneous injection
On September 19, 2025, the Food and Drug Administration approved pembrolizumab and berahyaluronidase alfa-pmph for…
FDA-approved MI cancer seek test enhances tumour profiling for precision oncology
A new research paper was published in Volume 16 of Oncotarget on August 13, 2025, titled “Clinical…
FDA grants accelerated approval to zongertinib for non-squamous NSCLC with HER2 TKD activating mutations
On August 8, 2025, the Food and Drug Administration granted accelerated approval to zongertinib, a…
FDA grants accelerated approval to linvoseltamab-gcpt for relapsed or refractory multiple myeloma
On July 2, 2025, the Food and Drug Administration granted accelerated approval to linvoseltamab-gcpt, a…
FDA grants accelerated approval to sunvozertinib for metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations
On July 2, 2025, the Food and Drug Administration granted accelerated approval to sunvozertinib Pharmaceutical…
FDA approves tafasitamab-cxix for relapsed or refractory follicular lymphoma
On June 18, 2025, the Food and Drug Administration approved tafasitamab-cxix with lenalidomide and rituximab…
FDA approves penpulimab-kcqx for non-keratinizing nasopharyngeal carcinoma
On April 23, 2025, the Food and Drug Administration approved penpulimab-kcqx with cisplatin or carboplatin…