Drugs.com - New Drug Approvals
New drug approvals news from Drugs.com. Comprehensive, up-to-date drug news for consumers and healthcare professionals.
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FDA Grants Accelerated Approval to Hepcludex (bulevirtide-gmod) Treatment for Chronic Hepatitis Delta Virus (HDV)
FOSTER CITY, Calif.--(BUSINESS WIRE) May 22, 2026 -- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Hepcludex (bulevirtide-gmod) 8.5 mg for the treatment... -
FDA Approves Baxfendy (baxdrostat) as the First Aldosterone Synthase Inhibitor Treatment for Adults with Hypertension
May 18, 2026 -- AstraZeneca’s Baxfendy (baxdrostat) has been approved in the US as a first-in-class aldosterone synthase inhibitor (ASI) for the treatment of hypertension in combination with other antihypertensive medications, to lower blood... -
FDA Approves Trimbow (beclomethasone/formoterol/glycopyrrolate) Inhaler for the Maintenance Treatment of Asthma
Cary, N.C., May 18, 2026—Chiesi USA, Inc. (key-A-zee), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration has approved Trimbow (beclomethasone dipropionate/formoterol fumarate/glycopyrrolate; or... -
FDA Approves Immgolis Intri (golimumab-sldi), an Interchangeable Biosimilar to Simponi Aria (golimumab)
RALEIGH, N.C., May 18, 2026 /PRNewswire/ — Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd. ("Intas Pharmaceuticals"), focused on the development of oncology, immunology and central nervous system (CNS)... -
FDA Approves Immgolis (golimumab-sldi), an Interchangeable Biosimilar to Simponi
RALEIGH, N.C., May 18, 2026 /PRNewswire/ — Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd. ("Intas Pharmaceuticals"), focused on the development of oncology, immunology and central nervous system (CNS)... -
FDA Approves Genentech’s Tecentriq for Adjuvant Muscle-Invasive Bladder Cancer With ctDNA-Guided Treatment
South San Francisco, CA -- May 15, 2026 -- Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) and Tecentriq Hybreza®... -
Enhertu Approved in the US for Two New Indications for Patients with HER2 Positive Early Breast Cancer
Tokyo – (May 15, 2026) – Enhertu (fam-trastuzumab deruxtecan-nxki) has been approved by the U.S. Food and Drug Administration (FDA) for two new breast cancer indications in the neoadjuvant and adjuvant settings of patients with HER2... -
Fasenra Approved in US for Hypereosinophilic Syndrome
14 May 2026 -- AstraZeneca’s Fasenra (benralizumab) has been approved by the US FDA for the treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) without an identifiable non-hematologic...