FDA Approval

FDA Approves Tovorafenib for Pediatric Low-Grade Glioma With BRAF Mutation

By: Dr. Anish Shah Bronx-Lebanon Hospital; Bronx, NY On April 23, 2024, the U.S. Food and Drug Administration granted accelerated approval for…

6 months ago

FDA Approves Tisotumab Vedotin for Recurrent or Metastatic Cervical Cancer

By: Dr. Anish Shah Bronx-Lebanon Hospital; Bronx, NY On April 29, 2024, the U.S. Food and Drug Administration granted regular approval to…

6 months ago

FDA Approves Lutetium Lu 177 Dotatate for SSTR-Positive Gastroenteropancreatic Neuroendocrine Tumors

By: Dr. Anish Shah Bronx-Lebanon Hospital; Bronx, NY On April 23, 2024, the U.S. Food and Drug Administration granted approval for lutetium…

6 months ago

FDA Approves Alectinib for Adjuvant Treatment in Non-Small Cell Lung Cancer

By: Dr. Anish Shah Bronx-Lebanon Hospital; Bronx, NY On April 18, 2024, the U.S. Food and Drug Administration granted approval to a…

6 months ago

FDA grants approval to Nogapendekin alfa inbakicept-pmln for bladder cancer

By: Dr. Anish Shah Bronx-Lebanon Hospital; Bronx, NY On April 22, 2024, the U.S. Food and Drug Administration granted approval for nogapendekin…

6 months 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

FDA Approves Talazoparib and Enzalutamide for Metastatic Castration-Resistant Prostate Cancer with HRR Gene Mutation

On June 20, 2023, the U.S. Food and Drug Administration approved talazoparib (Talzenna, Pfizer, Inc.) in combination with enzalutamide for…

1 year ago

FDA Grants Accelerated Approval to Glofitamab-gxbm for Relapsed/Refractory DLBCL

On June 15, 2023, the U.S. Food and Drug Administration approved Glofitamab-gxbm (Columvi) for the treatment of adult patients with…

1 year ago

FDA Grants Accelerated Approval to Epcoritamab for Relapsed or Refractory Diffuse Large B-cell Lymphoma and High-Grade B-cell Lymphoma

On May 19, 2023, Epcoritamab-bysp (Epkinly, Genmab US, Inc) was granted accelerated approval by the US FDA for the treatment…

1 year ago

FDA Grants Approval to Avapritinib for Indolent Systemic Mastocytosis

On May 22, 2023, the U.S. Food and Drug Administration approved avapritinib (Ayvakit) for the treatment of adults with indolent…

1 year ago