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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...

Nivolumab with ipilimumab is approved by the USFDA for unresectable or metastatic hepatocellular carcinoma

On April 11, 2025, the Food and Drug Administration sanctioned nivolumab (Opdivo, Bristol Myers Squibb Company) in conjunction with ipilimumab (Yervoy, Bristol Myers Squibb Company) for the first trea...

Nivolumab with ipilimumab is approved by the USFDA for unresectable or metastatic MSI-H or dMMR colorectal cancer

On April 8, 2025, the Food and Drug Administration approved nivolumab (Opdivo, Bristol Myers Squibb Company) and ipilimumab (Yervoy, Bristol Myers Squibb Company) for adults and children 12 years and ...

Durvalumab is approved by the USFDA for muscle invasive bladder cancer

On March 28, 2025, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) to be used with gemcitabine and cisplatin as a first treatment, followed by durvalumab alone as a follow-...

The FDA has broadened the indication for Pluvicto to include metastatic castration-resistant prostate cancer

On March 28, 2025, the Food and Drug Administration expanded the use of lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis Pharmaceuticals Corporation) to include adults with prostate-specific ...

Cabozantinib is approved by the USFDA for adults and pediatric patients 12 years of age and older with pNET and epNET

On March 26, 2025, the Food and Drug Administration sanctioned cabozantinib (Cabometyx, Exelixis, Inc.) for adult and pediatric patients aged 12 and older with previously treated, unresectable, locall...

Pembrolizumab is approved by the USFDA for HER2 positive gastric or gastroesophageal junction adenocarcinoma expressing PD-L1 (CPS ≥1)

On March 19, 2025, the Food and Drug Administration officially approved pembrolizumab (Keytruda, Merck) to be used along with trastuzumab and chemotherapy that includes fluoropyrimidine and platinum f...

Datopotamab deruxtecan-dlnk is approved by the USFDA for unresectable or metastatic, HR-positive, HER2-negative breast cancer

On January 17, 2025, the Food and Drug Administration sanctioned datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo, Inc.), a Trop-2-targeted antibody and topoisomerase inhibitor conjugate, for adu...

Ensartinib is approved by the USFDA for ALK-positive locally advanced or metastatic non-small cell lung cancer

 On December 18, 2024, the Food and Drug Administration sanctioned ensartinib (Ensacove, Xcovery Holdings, Inc.) for adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or ...

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