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FDA Approvals, News & Updates

On November 22, 2023, the FDA approved efbemalenograstim alfa-vuxw (Ryzneuta; Evive Biotech) subcutaneous injection, a novel long-acting granulocyte colony-stimulating factor (G-CSF), for the prevention and treatment of febrile neutropenia in adults with nonmyeloid malignancies who are receiving myelosuppressive chemotherapy associated with a clinically significant incidence of febrile neutropenia. Read More ›

On November 16, 2023, the FDA approved capivasertib (Truqap; AstraZeneca Pharmaceuticals), in combination with fulvestrant, for the treatment of hormone receptor (HR)-positive, HER2-negative, locally advanced or metastatic breast cancer in patients with ≥1 PIK3CA, AKT1, or PTEN genetic mutations, as detected by an FDA-approved test. Read More ›

On November 15, 2023, the FDA approved repotrectinib (Augtyro; Bristol Myers Squibb), a ROS1 tyrosine kinase inhibitor (TKI), for the treatment of patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) associated with ROS1 fusion. Read More ›

On November 16, 2023, the FDA approved a supplemental new drug application for enzalutamide (Xtandi; Astellas Pharma and Pfizer), an androgen receptor signaling inhibitor, for the treatment of nonmetastatic, castration-sensitive prostate cancer with biochemical recurrence (BCR) at high risk for metastasis (high-risk BCR). Read More ›

On November 9, 2023, the FDA approved Flowflex COVID-19 Antigen Home Test (Flowflex; ACON Laboratories), the first over-the-counter (OTC) antigen test for COVID-19 for use by individuals aged ≥14 years. Read More ›

On November 27, 2023, the FDA approved nirogacestat (Ogsiveo; SpringWorks Therapeutics) for adults with progressing desmoid tumors who require systemic treatment. Read More ›

On December 1, 2023, the FDA accelerated the approval of pirtobrutinib (Jaypirca; Eli Lilly) for the treatment of adults with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received ≥2 lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor. Read More ›

On November 8, 2023, the FDA approved fruquintinib (Fruzaqla; Takeda Pharmaceuticals), an inhibitor of VEGFR-1, -2, and -3, for the treatment of metastatic colorectal cancer in adults who received previous fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy. The FDA granted fruquintinib priority review for this indication. Read More ›

On October 27, 2023, the FDA approved toripalimab-tpzi (Loqtorzi; Coherus BioSciences), a PD-1 monoclonal antibody, in combination with cisplatin and gemcitabine chemotherapy, for the first-line treatment of adults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma, and as a single agent for adults with recurrent, unresectable, or metastatic nasopharyngeal carcinoma that progressed during or after treatment with a platinum-containing chemotherapy. Read More ›

On November 16, 2023, the FDA approved the use of pembrolizumab (Keytruda; Merck) with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. The FDA granted pembrolizumab an orphan drug designation for this indication. Read More ›

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