New Drug Applications

Category for ‘New Approval’ page. Covers FDA approved drugs.

The U.S. Food and Drug Administration approved Pembrolizumab (Keytruda) plus fluoropyrimidine- and platinum-containing chemotherapy as the first line treatment for adults

By: Dr. Anish Shah Bronx-Lebanon Hospital; Bronx, NY On November 16, 2023, the U.S. Food and Drug Administration approved Pembrolizumab (Keytruda) plus…

11 months ago

FDA Approves Nirogacestat for Adult Patients with Progressing Desmoid Tumors

By: Dr. Anish Shah Bronx-Lebanon Hospital; Bronx, NY On the date of approval, the U.S. Food and Drug Administration approved Nirogacestat (Ogsiveo)…

11 months ago

Capivasertib Gets FDA Approval for Treatment of HR-Positive, HER2-Negative Breast Cancer

By: Dr. Anish Shah Bronx-Lebanon Hospital; Bronx, NY   On November 16, 2023, the U.S. Food and Drug Administration approved capivasertib (Truqap,…

11 months ago

FDA Grants accelerated approval to Pirtobrutinib for Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma with Prior Therapy

By: Dr. Anish Shah Bronx-Lebanon Hospital; Bronx, NY The U.S. Food and Drug Administration granted accelerated approval for Pirtobrutinib (Jaypirca) to be…

11 months ago

FDA approves Encorafenib with Binimetinib for metastatic non-small cell lung cancer.

On October 11, 2023, the U.S. Food and Drug Administration granted approval to Encorafenib (BRAF inhibitor) with Binimetinib (MEK inhibitor)…

1 year ago

FDA Approves Bosutinib for Pediatric Patients with Philadelphia Chromosome–Positive Chronic Myelogenous Leukemia

On September 26, the U.S. Food and Drug Administration expanded the approval of bosutinib (Bosulif) to include pediatric patients 1…

1 year ago

FDA Approves HEPZATO KIT for Uveal Melanoma with Unresectable Hepatic Metastases

By Dr. Anish Shah Bronx-Lebanon Hospital   On August 14, 2023, the U.S. Food and Drug Administration approved HEPZATO KIT…

1 year ago

FDA Approves Elranatamab-bcmm for Multiple Myeloma with Relapsed or Refractory Status

By Dr. Anish Shah Bronx-Lebanon Hospital   On August 14, 2023, the U.S. Food and Drug Administration granted accelerated approval…

1 year ago

FDA approves niraparib and abiraterone acetate plus prednisone for metastatic prostate cancer With BRCA Mutation

By Dr. Anish Shah Bronx Lebanon Hospital   On August 11, 2023, the U.S. Food and Drug Administration granted regular…

1 year ago

FDA Approves Talquetamab-Tgvs For Adults with Relapsed Or Refractory Multiple Myeloma Patients with at least Four Prior Lines of Therapy

By Dr. Anish Shah Bronx Lebanon Hospital   On August 9, 2023, the U.S. Food and Drug Administration approved talquetamab-tgvs…

1 year ago