RX Professionals Resources and Support

July 15, 2025

Dificid® (fidaxomicin) – First-time generic

July 15, 2025 - Teva launched an AB-rated generic version of Merck’s Dificid (fidaxomicin) tablets.

July 15, 2025

Kirsty™ (insulin aspart-xjhz) – New first-time interchangeable biosimilar approval

July 15, 2025 - The FDA approved Biocon Biologics’ Kirsty (insulin aspart-xjhz), biosimilar and interchangeable to Novo Nordisk’s Novolog® (insulin aspart).

July 14, 2025

Kerendia® (finerenone) – New indication

July 14, 2025 - Bayer announced the FDA approval of Kerendia (finerenone), to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adult patients with heart failure with left ventricular ejection fraction (LVEF) ≥ 40%.

July 11, 2025

Spikevax® (COVID-19 vaccine, mRNA) – Expanded indication

July 11, 2025 - Moderna announced the FDA approval of Spikevax (COVID-19 vaccine, mRNA), for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) for use in individuals who are: 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.

July 7, 2025

Ekterly® (sebetralstat) – New orphan drug approval

July 7, 2025 - KalVista Pharmaceuticals announced the FDA approval of Ekterly (sebetralstat), for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older.

July 2, 2025

Lynozyfic™ (linvoseltamab-gcpt) – New drug approval

July 2, 2025 - Regeneron announced the FDA approval of Lynozyfic (linvoseltamab-gcpt), for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

July 2, 2025

Zegfrovy® (sunvozertinib) – New drug approval

July 2, 2025 - The FDA announced the approval of Dizal Pharmaceuticals’ Zegfrovy (sunvozertinib), for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

June 30, 2025

Extended-release stimulants for ADHD – FDA warns of weight loss risk in patients < 6 years old

June 30, 2025 - The FDA announced it is revising the labeling of all extended-release stimulants indicated to treat attention-deficit/hyperactivity disorder (ADHD) – including certain formulations of amphetamine and methylphenidate – to warn about the risk of weight loss and other adverse reactions in patients younger than 6 years taking these medications.

June 28, 2025

Gamifant® (emapalumab-lzsg) – New indication

June 28, 2025 - Sobi announced the FDA approval of Gamifant (emapalumab-lzsg), for the treatment of adult and pediatric (newborn and older) patients with hemophagocytic lymphohistiocytosis (HLH)/macrophage activation syndrome (MAS) in known or suspected Still’s disease, including systemic juvenile idiopathic arthritis (sJIA), with an inadequate response or intolerance to glucocorticoids, or with recurrent MAS.

June 26, 2025

CAR T cell immunotherapies – Updated labeling and elimination of REMS

June 26, 2025 - The FDA approved updated labeling for currently approved BCMA- and CD19-directed autologous chimeric antigen receptor (CAR) T cell immunotherapies and eliminated the Risk Evaluation and Mitigation Strategies (REMS) program for these products.

June 24, 2025

Elevidys® (delandistrogene moxeparvovec-rokl) – FDA safety communication

June 24, 2025 - The FDA announced that the agency has received two reports of fatal acute liver failure following treatment of non-ambulatory pediatric male patients with Duchenne muscular dystrophy (DMD) with Elevidys (delandistrogene moxeparvovec-rokl).

June 23, 2025

Datroway® (datopotamab deruxtecan-dlnk) – New indication

June 23, 2025 - The FDA announced the approval of AstraZeneca and Daiichi Sankyo’s Datroway (datopotamab deruxtecan-dlnk), for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy.

June 20, 2025

Descovy® (emtricitabine/tenofovir alafenamide), Tybost® (cobicistat) – Updated indications

June 20, 2025 - The FDA approved an updated indication for Gilead’s Descovy (emtricitabine/tenofovir alafenamide), for the treatment of HIV-1 infection in pediatric patients weighing at least 14 kg to less than 35 kg in combination with other antiretroviral agents, including darunavir and cobicistat but not other protease inhibitors that require a CYP3A inhibitor.

June 17, 2025

Complera® (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) – First-time generic

June 17, 2025 - Mylan/Viatris launched an AB-rated generic version of Gilead/Janssen’s Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) tablets.

June 1, 2025

RxHighlights - June 2025 Edition

March 31, 2025

Imfinzi® (durvalumab) – New indication

March 31, 2025 - AstraZeneca announced the FDA approval of Imfinzi (durvalumab), in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent Imfinzi as adjuvant treatment following radical cystectomy, for the treatment of adult patients with muscle invasive bladder cancer (MIBC).

March 31, 2025

Medicare drug coverage and your rights

Download the current CMS pharmacy notices.

March 20, 2025

Auryxia® (ferric citrate) – First-time authorized generic alternative

March 20, 2025 - Mylan/Viatris launched an authorized generic alternative of Keryx Biopharmaceuticals/Akebia Therapeutics’ Auryxia (ferric citrate) tablets.

March 4, 2025

Soliris® (eculizumab) – Expanded indication

February 28, 2025 - The FDA approved AstraZeneca’s Soliris (eculizumab), for the treatment of generalized myasthenia gravis (gMG) in adult and pediatric patients 6 years of age and older who are anti-acetylcholine receptor (AChR) antibody positive.

March 4, 2025

Odactra® (Dermatophagoides farinae and Dermatophagoides pteronyssinus) – Expanded indication

February 27, 2025 - ALK announced the FDA approval of Odactra (Dermatophagoides farinae and Dermatophagoides pteronyssinus), for the treatment of house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis, confirmed by positive in vitro testing for IgE antibodies to Dermatophagoides farinae or Dermatophagoides pteronyssinus house dust mites, or by positive skin testing to licensed house dust mite allergen extracts. Odactra is approved for use in individuals 5 through 65 years of age.

March 4, 2025

Osenvelt® (denosumab-bmwo) – New biosimilar approval

March 3, 2025 - Celltrion announced the FDA approval of Osenvelt (denosumab-bmwo), biosimilar to Amgen’s Xgeva® (denosumab).

March 4, 2025

Stoboclo® (denosumab-bmwo) – New biosimilar approval

March 3, 2025, Celltrion announced the FDA approval of Stoboclo (denosumab-bmwo), biosimilar to Amgen’s Prolia® (denosumab).

February 28, 2025

Ascent Consumer Products – Recall of SinuCleanse® Soft Tip Squeeze Bottle Nasal Wash System

February 25, 2025 - Ascent Consumer Products announced a consumer level recall of one lot of SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System because of a confirmed test result of microbial contamination of the product with Staphylococcus aureus (S. aureus).

February 28, 2025

Purixan® (mercaptopurine) – First-time generic

February 27, 2025 - Hikma launched an AB-rated generic version of Nova Laboratories’ Purixan (mercaptopurine) oral suspension.