Category: Drug Approvals

Home / Drug Approvals

Categories

Neoadjuvant and adjuvant pembrolizumab is approved by the USFDA for resectable locally advanced head and neck squamous cell carcinoma

On June 12, 2025, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) for adults with advanced head and neck squamous cell carcinoma (HNSCC) that can be surgically removed and sh...

Mitomycin intravesical solution is approved by the USFDA for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer

On June 12, 2025, the Food and Drug Administration approved mitomycin intravesical solution (Zusduri, UroGen Pharma) for adults with recurring low-grade intermediate-risk non-muscle invasive bladder c...

Taletrectinib is approved by the USFDA for ROS1-positive non-small cell lung cancer

On June 11, 2025, the Food and Drug Administration approved taletrectinib (Ibtrozi, Nuvation Bio Inc.), a type of medicine that blocks certain enzymes, for people with advanced or spreading ROS1-posit...

Darolutamide is approved by the USFDA for metastatic castration-sensitive prostate cancer

On June 3, 2025, the Food and Drug Administration (FDA) sanctioned darolutamide (Nubeqa, Bayer Healthcare Pharmaceuticals Inc.) for metastatic castration-sensitive prostate cancer (mCSPC). The FDA has...

Retifanlimab-dlwr with carboplatin and paclitaxel is approved by the USFDA and as a single agent for squamous cell carcinoma of the anal canal

On May 15, 2025, the Food and Drug Administration sanctioned retifanlimab-dlwr (Zynyz, Incyte Corporation) in conjunction with carboplatin and paclitaxel for the initial treatment of people with inope...

Accelerated approval is granted by the USFDA to telisotuzumab vedotin-tllv for NSCLC with high c-Met protein overexpression

On May 14, 2025, the Food and Drug Administration granted accelerated approval for telisotuzumab vedotin-tllv (Emrelis, AbbVie Inc.), a c-Met-targeted antibody and microtubule inhibitor conjugate, for...

Belzutifan is approved by the USFDA for pheochromocytoma or paraganglioma

On May 14, 2025, the Food and Drug Administration sanctioned belzutifan (Welireg, Merck & Co., Inc.) for adult and pediatric patients aged 12 and older diagnosed with locally advanced, unresectabl...

Accelerated approval is granted by the USFDA to the combination of avutometinib and defactinib for KRAS-mutated recurrent low-grade serous ovarian cancer

On May 8, 2025, the Food and Drug Administration approved the use of avutometinib and defactinib (Avmapki Fakzynja Co-pack, Verastem, Inc.) for adults with KRAS-mutated recurrent low-grade serous ovar...

Penpulimab-kcqx is approved by the USFDA for non-keratinizing nasopharyngeal carcinoma

On April 23, 2025, the Food and Drug Administration sanctioned penpulimab-kcqx (Akeso Biopharma Co., Ltd.) in conjunction with cisplatin or carboplatin and gemcitabine for the initial treatment of peo...

Breakthrough in Cancer Treatment: FDA Approves Drug from Small Enterprise in Tianjin, China

Introduction In a stunning surprise that has stunned the international biotech industry, a tiny and micro business in Tianjin, China, has come up with an anti-cancer medication that just won official...

We Are Online! Chat With Us!
Scan the code