Latest posts
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FDA Approves Foundayo for Chronic Weight Management in Adults
What Was Approved? On April 1, 2026, the U.S. Food and Drug Administration approved Foundayo (orforglipron) for chronic weight management in adults with: Foundayo is used together with a reduced-calorie diet and increased physical activity. What Is Foundayo? Foundayo is an oral GLP-1 receptor agonist. Unlike injectable GLP-1 medicines, Foundayo is taken as a tablet…
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FDA Approves Idvynso as a Two-Drug HIV-1 Treatment Regimen
What Was Approved? On April 20, 2026, the U.S. Food and Drug Administration approved Idvynso (doravirine and islatravir) as a complete treatment regimen for certain adults with HIV-1 infection. It is intended to replace a current antiretroviral regimen in adults who: Idvynso is not approved as an initial treatment for every person newly diagnosed with…
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FDA Approves Veppanu for Certain ESR1-Mutated Advanced Breast Cancers
What Was Approved? On May 1, 2026, the U.S. Food and Drug Administration approved Veppanu (vepdegestrant) for adults with: Veppanu is not approved for every patient with ER-positive breast cancer. How Does Veppanu Work? Veppanu is a heterobifunctional protein degrader. It is designed to promote degradation of the estrogen receptor, which can help interfere with…
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FDA Approves Beqalzi for Previously Treated Mantle Cell Lymphoma
What Was Approved? On May 13, 2026, the U.S. Food and Drug Administration granted accelerated approval to Beqalzi (sonrotoclax) for adults with relapsed or refractory mantle cell lymphoma, or MCL, after at least two prior lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor. Beqalzi is not approved as a general first-line treatment…
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FDA Approves Zaynich for Complicated Urinary Tract Infections
What Was Approved? On May 29, 2026, the U.S. Food and Drug Administration approved Zaynich (cefepime and zidebactam) for adults with complicated urinary tract infections, including pyelonephritis, caused by designated susceptible bacteria. Zaynich combines: How Is Zaynich Given? For adults with an estimated glomerular filtration rate of at least 60 mL/min, the recommended dose is:…
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FDA Approves Decnupaz for Adults With BPDCN
What Was Approved? On May 27, 2026, the U.S. Food and Drug Administration approved Decnupaz (pivekimab sunirine-pvzy) for the treatment of adults with blastic plasmacytoid dendritic cell neoplasm, or BPDCN. BPDCN is a rare and aggressive blood cancer that can involve the bone marrow, blood, skin, lymph nodes, and other organs. What Is Decnupaz? Decnupaz…
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FDA Approves Hepcludex for Chronic Hepatitis Delta Virus Infection
What Was Approved? On May 22, 2026, the U.S. Food and Drug Administration approved Hepcludex (bulevirtide-gmod) for the treatment of chronic hepatitis delta virus, or HDV, infection in adults: Hepcludex is the first FDA-approved treatment specifically for chronic HDV infection in the United States. What Is Hepatitis Delta? Hepatitis delta is a serious liver infection…
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FDA Approves Xocova for Post-Exposure Prevention of COVID-19
What Was Approved? On May 29, 2026, the U.S. Food and Drug Administration approved Xocova (ensitrelvir) for post-exposure prophylaxis of COVID-19 in adults and adolescents 12 years of age and older after contact with someone who has COVID-19. Xocova is intended to reduce the risk of developing COVID-19 after a known exposure. It is not…
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FDA Approves Cypsedo for Induction of General Anesthesia in Adults
What Was Approved? On May 29, 2026, the U.S. Food and Drug Administration approved Cypsedo (cipepofol) for the induction of general anesthesia in adults undergoing surgery. Cypsedo is given intravenously and is intended for use by trained healthcare professionals in a monitored medical setting. How Is Cypsedo Given? Cypsedo is administered by intravenous injection shortly…
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FDA Approves Ambelvist for Contrast-Enhanced MRI
What Was Approved? On June 12, 2026, the U.S. Food and Drug Administration approved Ambelvist (gadoquatrane) for use with magnetic resonance imaging, or MRI, to help detect and visualize lesions with abnormal vascularity. It is approved for adults and pediatric patients, including term neonates. Where Can Ambelvist Be Used? Ambelvist may be used for MRI…