By: Dr. Anish Shah Bronx-Lebanon Hospital; Bronx, NY The U.S. Food and Drug Administration granted accelerated approval for Pirtobrutinib (Jaypirca) to be administered to adult patients diagnosed with chronic lymphocytic leukemia (CLL) or small
By: Dr. Anish Shah Bronx-Lebanon Hospital; Bronx, NY On April 23, 2024, the U.S. Food and Drug Administration granted accelerated approval for tovorafenib (Ojemda, Day One Biopharmaceuticals, Inc.) for relapsed or refractory pediatric low-grade
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By: Dr. Anish Shah Bronx-Lebanon Hospital; Bronx, NY On April 29, 2024, the U.S. Food and Drug Administration granted regular approval to tisotumab vedotin-tftv (Tivdak, Seagen Inc. [now a part of Pfizer Inc.]) for
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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 Lu 177 dotatate (Lutathera, Advanced Accelerator Applications USA, Inc., a Novartis company)
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By: Dr. Anish Shah Bronx-Lebanon Hospital; Bronx, NY On April 18, 2024, the U.S. Food and Drug Administration granted approval to a potent oral ALK (anaplastic lymphoma kinase) tyrosine kinase inhibitor – Alectinib (Alecensa,
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By: Dr. Anish Shah Bronx-Lebanon Hospital; Bronx, NY On April 22, 2024, the U.S. Food and Drug Administration granted approval for nogapendekin alfa inbakicept-pmln (Anktiva, Altor BioScience, LLC), to be used in conjunction with
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By: Dr. Anish Shah Bronx-Lebanon Hospital; Bronx, NY On February 13, 2024, the U.S. Food and Drug Administration granted approval for the use of irinotecan liposome (Onivyde, Ipsen Biopharmaceuticals, Inc.) as a combined treatment
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By: Dr. Anish Shah Bronx-Lebanon Hospital; Bronx, NY On December 13, 2023, the U.S. Food and Drug Administration granted approval to eflornithine (IWILFIN, USWM, LLC) for adult and pediatric patients with high-risk neuroblastoma (HRNB)
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By: Dr. Anish Shah Bronx-Lebanon Hospital; Bronx, NY The U.S. Food and Drug Administration gave its approval for the use of enfortumab vedotin-ejfv (Padcev, Astellas Pharma) in combination with pembrolizumab (Keytruda, Merck) as a
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By: Dr. Anish Shah Bronx-Lebanon Hospital; Bronx, NY On December 14, 2023, the U.S. Food and Drug Administration granted approval to belzutifan (Welireg, Merck & Co., Inc.) for patients with advanced renal cell carcinoma
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By: Dr. Anish Shah Bronx-Lebanon Hospital; Bronx, NY On November 16, 2023, the U.S. Food and Drug Administration approved Pembrolizumab (Keytruda) plus fluoropyrimidine- and platinum-containing chemotherapy as the first line treatment for adults with
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