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Cosibelimab-ipdl is approved by the USFDA for metastatic or locally advanced cutaneous squamous cell carcinoma

 On December 13, 2024, the Food and Drug Administration sanctioned cosibelimab-ipdl (Unloxcyt, Checkpoint Therapeutics, Inc.), a programmed death ligand-1 (PD-L1) inhibiting antibody, for adults with...

Durvalumab is approved by the USFDA for limited-stage small cell lung cancer

 On December 4, 2024, the Food and Drug Administration sanctioned durvalumab (Imfinzi, AstraZeneca) for adults with limited-stage small cell lung cancer (LS-SCLC) whose condition remains stable after...

Zenocutuzumab-zbco is approved by the USFDA for non-small cell lung cancer and pancreatic adenocarcinoma

 On December 4, 2024, the Food and Drug Administration granted accelerated approval to zenocutuzumab-zbco (Bizengri, Merus N.V.) for use in adults with specific conditions.Patients with advanced, unr...

Zanidatamab-hrii is approved by the USFDA for previously treated unresectable or metastatic HER2-positive biliary tract cancer

 On November 20, 2024, the Food and Drug Administration granted accelerated approval for zanidatamab-hrii (Ziihera, Jazz Pharmaceuticals, Inc.), a bispecific HER2-targeted antibody, for previously tr...

Revumenib is approved by the USFDA for relapsed or refractory acute leukemia with a KMT2A translocation

 On November 15, 2024, the Food and Drug Administration sanctioned revumenib (Revuforj, Syndax Pharmaceuticals, Inc.), a menin inhibitor, for relapsed or refractory acute leukemia characterized by a ...

Obecabtagene autoleucel for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia

On November 8, 2024, the Food and Drug Administration sanctioned obecabtagene autoleucel (Aucatzyl, Autolus Inc.), a CD19-targeted genetically engineered autologous CAR T cell therapy, for people with...

Asciminib is approved by the USFDA for newly diagnosed chronic myeloid leukemia

 On October 29, 2024, the Food and Drug Administration approved asciminib (Scemblix, Novartis AG) for adults who have just been diagnosed with Philadelphia chromosome-positive chronic myeloid leukemi...

Zolbetuximab-clzb with chemotherapy is approved by the USFDA for gastric or gastroesophageal junction adenocarcinoma

 On October 18, 2024, the Food and Drug Administration sanctioned zolbetuximab-clzb (Vyloy, Astellas Pharma US, Inc.), a claudin 18.2 (CLDN18.2)-targeted cytolytic antibody, in conjunction with fluor...

Inavolisib with palbociclib and fulvestrant for endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, advanced breast cancer

 On October 10, 2024, the Food and Drug Administration authorized inavolisib (Itovebi, Genentech, Inc.) in conjunction with palbociclib and fulvestrant for adults diagnosed with endocrine-resistant, ...

Neoadjuvant/adjuvant nivolumab is approved by the USFDA for resectable non-small cell lung cancer

 On October 3, 2024, the Food and Drug Administration sanctioned nivolumab (Opdivo, Bristol Myers Squibb Company) in conjunction with platinum-doublet chemotherapy as neoadjuvant therapy, succeeded b...

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