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Clinical Publications
Access information on drug therapy issues impacting today's health care and pharmacy environment. Within the category filter below select Rx Highlights, Rx News, and Rx Outlook to view the latest publications. Rx News can also be filtered by Type or use the search to look for the drug by name.
Optum Rx news and resources (414)
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August 12, 2025
Brinsupri™ (brensocatib) – New drug approval
August 12, 2025 - Insmed announced the FDA approval of Brinsupri (brensocatib), for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult and pediatric patients 12 years of age and older.
August 11, 2025
Venofer® (iron sucrose) – First-time generic
August 11, 2025 - Viatris launched an AB-rated generic version of American Regent’s Venofer (iron sucrose) injection.
August 8, 2025
Grifols – Withdrawal of Gamunex®-C (immune globulin [human]) 10% injection
August 8, 2025 - Grifols Therapeutics announced a voluntary, consumer level withdrawal of two lots of Gamunex-C (immune globulin [human]) 10% injection because of an increased rate of allergic/hypersensitivity type reactions.
August 8, 2025
Hernexeos® (zongertinib) – New drug approval
August 8, 2025 - The FDA announced the approval of Boehringer Ingelheim’s Hernexeos (zongertinib), for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy.
August 7, 2025
Skysona® (elivaldogene autotemcel) – Updated labeling
August 7, 2025 - The FDA approved several labeling changes for Skysona (elivaldogene autotemcel) due to new safety information on the increased risk of hematologic malignancy.
August 6, 2025
Ixchiq® (Chikungunya vaccine, live) – FDA removes pause in use in patients 60 years and older
August 6, 2025 - The FDA removed the recommended pause in the use of Ixchiq (Chikungunya vaccine, live) in individuals 60 years of age and older and has approved updates to the prescribing information and patient information.
August 6, 2025
Ajovy® (fremanezumab-vfrm) – New indication
August 6, 2025 -Teva announced the FDA approval of Ajovy (fremanezumab-vfrm), for the preventive treatment of episodic migraine in pediatric patients who are 6 to 17 years of age and who weigh 45 kg or more.
August 6, 2025
Vuity® (pilocarpine) – First-time generic
August 6, 2025 - Amneal launched an AB-rated generic version of AbbVie’s Vuity (pilocarpine) ophthalmic solution.
August 6, 2025
Modeyso™ (dordaviprone) – New orphan drug approval
August 6, 2025 - The FDA announced the approval of Jazz Pharmaceuticals’ Modeyso (dordaviprone), for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.
July 31, 2025
Leqvio® (inclisiran) – Expanded indication
July 31, 2025 - Novartis announced the FDA approval of Leqvio (inclisiran), as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH).
July 31, 2025
Alhemo® (concizumab-mtci) – Expanded indication
July 31, 2025 - Novo Nordisk announced the FDA approval of Alhemo (concizumab-mtci), for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with Hemophilia A (congenital factor VIII deficiency) with or without FVIII inhibitors; Hemophilia B (congenital factor IX deficiency) with or without FIX inhibitors.
July 31, 2025
Long-term opioid analgesic use – FDA requires updated prescribing information
July 31, 2025 - The FDA announced it is requiring safety labeling changes for opioid pain medicines to further emphasize and characterize the risks associated with long-term use.
July 31, 2025
Vizz™ (aceclidine) – New drug approval
July 31, 2025 - LENZ Therapeutics announced the FDA approval of Vizz (aceclidine), for the treatment of presbyopia in adults.
July 30, 2025
Atmeksi® (methocarbamol) – New drug approval
July 30, 2025 - The FDA approved Rosemont Pharmaceuticals’ Atmeksi (methocarbamol) oral suspension, as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions in patients 16 and older.
July 30, 2025
Biktarvy® (bictegravir/emtricitabine/tenofovir alafenamide) – Expanded indication
July 30, 2025 - The FDA approved Gilead’s Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide), as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 14 kg with an antiretroviral treatment history and not virologically suppressed, with no known or suspected substitutions associated with resistance to the integrase strand inhibitor class, emtricitabine, or tenofovir.
July 29, 2025
Vyscoxa™ (celecoxib) – New drug approval
July 29, 2025 - The FDA approved Carwin Pharmaceutical’s Vyscoxa (celecoxib) oral suspension in adults for the management of the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis; in pediatric patients two years of age and older for the management of the signs and symptoms of juvenile rheumatoid arthritis.
July 28, 2025
Sirturo® (bedaquiline) – Expanded indication
July 28, 2025 - The FDA approved Janssen’s Sirturo (bedaquiline), as part of combination therapy in adult and pediatric patients (2 years and older and weighing at least 8 kg) with pulmonary tuberculosis (TB) due to Mycobacterium tuberculosis resistant to at least rifampin and isoniazid.
July 28, 2025
Skytrofa® (lonapegsomatropin-tcgd) – Expanded indication
July 28, 2025 - Ascendis Pharma announced the FDA approval of Skytrofa (lonapegsomatropin-tcgd), for the replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD).
July 28, 2025
Sephience™ (sepiapterin) – New orphan drug approval
July 28, 2025 - PTC Therapeutics announced the FDA approval of Sephience (sepiapterin), for the treatment of hyperphenylalaninemia (HPA) in adult and pediatric patients 1 month of age and older with sepiapterin-responsive phenylketonuria (PKU).
July 28, 2025
Empaveli® (pegcetacoplan) – New indication
July 28, 2025 - Apellis announced the FDA approval of Empaveli (pegcetacoplan), for the treatment of adult and pediatric patients aged 12 years and older with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN), to reduce proteinuria.
July 25, 2025
Doptelet ® (avatrombopag) – Expanded indication, new formulation
July 25, 2025 - Sobi announced the FDA approval of Doptelet (avatrombopag), for the treatment of thrombocytopenia in pediatric patients 6 years and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.
July 24, 2025
Sdalmo (amlodipine) – New drug approval
July 24, 2025 - The FDA approved Brillian’s Sdalmo (amlodipine), which may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of hypertension, to lower blood pressure in adults and pediatric patients 6 years of age and older and for coronary artery disease (CAD) in adults (chronic stable angina, vasospastic angina [Prinzmetal's or variant angina], and angiographically documented CAD in patients without heart failure or an ejection fraction < 40%).
July 24, 2025
Anzupgo® (delgocitinib) – New drug approval
July 24, 2025 - LEO Pharma announced the FDA approval of Anzupgo (delgocitinib), for the topical treatment of moderate to severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable.
July 23, 2025
Vostally (ramipril) – New drug approval
July 23, 2025 - The FDA approved Rosemont Pharmaceuticals’ Vostally (ramipril) oral solution.
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