Rx Professionals Resources and Support

October 10, 2025

RxNews - October 10, 2025

COVID-19 and Measles, Mumps, Rubella and Varicella (MMRV) vaccines – CDC Director adopts ACIP recommendations
Tecentriq® (atezolizumab) or Tecentriq Hybreza® (atezolizumab/hyaluronidase-tqjs) plus Zepzelca® (lurbinectedin) – New indication
Zoryve® (roflumilast) – Expanded indication, new strength
Eydenzelt® (aflibercept-boav) – New biosimilar approval
Jascayd® (nerandomilast) – New orphan drug approval
Qivigy® (immune globulin intravenous, human-kthm) – New drug approval
Rhapsido® (remibrutinib) – New drug approval
Grifols – Withdrawal of Gamunex®-C (immune globulin [human]) 10% injection

October 3, 2025

RxNews - October 3, 2025

Caprelsa® (vandetanib) – Drug update (REMS removal)
Evkeeza® (evinacumab-dgnb) – Expanded indication
Tremfya® (guselkumab) – Expanded indications
Bondlido® (lidocaine) – New drug approval
Clotic (clotrimazole) – New drug approval
Enoby™ (denosumab-qbde) – New biosimilar approval
Inluriyo (imlunestrant) – New drug approval
Palsonify™ (paltusotine) – New orphan drug approval
Xtrenbo™ (denosumab-qbde) – New biosimilar approval
Endometrin® (progesterone) – First-time generic

September 26, 2025

RxNews - September 26, 2025

Aukelso™ (denosumab-kyqq) – New biosimilar approval
Bosaya™ (denosumab-kyqq) – New biosimilar approval
Forzinity™ (elamipretide) – New orphan drug approval
Keytruda Qlex™ (pembrolizumab/berahyaluronidase alfa-pmph) – New drug approval
Subvenite® (lamotrigine) – New drug approval
COVID-19, MMRV, and Hepatitis B vaccines – ACIP recommendations
Opzelura® (ruxolitinib) – Expanded indication
Tremfya® (guselkumab) – Updated dosing
Vyjuvek® (beremagene geperpavec-svdt) – Expanded indication
Dr. Reddy’s Laboratories – Withdrawal of ropinirole extended-release tablets

September 19, 2025

RxNews - September 19, 2025

Koselugo® (selumetinib) – Expanded indication, new formulation
Enbumyst™ (bumetanide) – New drug approval
Inlexzo™ (gemcitabine) – New drug approval
Zolymbus™ (bimatoprost) – New drug approval
Intercept – Withdrawal of Ocaliva® (obeticholic acid)

September 12, 2025

RxNews - September 12, 2025

Vonvendi® (von Willebrand factor [recombinant]) – Expanded indications
Otezla XR™ (apremilast) – New drug approval

September 11, 2025

RxOutlook - 3rd Quarter 2025

September 5, 2025

RxNews - September 5, 2025

Bildyos® (denosumab-nxxp) – New biosimilar approval
Bilprevda® (denosumab-nxxp) – New biosimilar approval
Camcevi ETM® (leuprolide) – New formulation approval
Comirnaty® (COVID-19 vaccine, mRNA) – New vaccine approval
Leqembi® (lecanemab-irmb) – New formulation approval, updated drug monitoring
mNEXSPIKE® (COVID-19 vaccine, mRNA) – New vaccine approval
Nuvaxovid™ (COVID-19 vaccine, adjuvanted) – New vaccine approval
Spikevax® (COVID-19 vaccine, mRNA) – New vaccine approval
Wayrilz™ (rilzabrutinib) – New orphan drug approval
Unichem – Recall of cyclobenzaprine tablets
Saxenda® (liraglutide) – First-time generic
Tracleer® (bosentan) tablets for oral suspension – First-time generic

August 29, 2025

RxNews - August 29, 2025

Repatha® (evolocumab) – Expanded/updated indications
Thrombate III® (antithrombin III [human]) – Expanded indication
Cyklx™ (articaine) – New drug approval
Dawnzera™ (donidalorsen) – New orphan drug approval
Eligard® (leuprolide) – First-time authorized brand alternative
Ixchiq® (chikungunya vaccine, live) – FDA suspends biologics license

August 22, 2025

RxNews - August 22, 2025

Actemra® (tocilizumab) – Expanded indication
Wegovy® (semaglutide) – New indication
Papzimeos™ (zopapogene imadenovec-drba) – New drug approval
Tonmya™ (cyclobenzaprine) – New drug approval
Celltrion – Recall of Steqeyma® (ustekinumab-stba) injection

August 20, 2025

OptumRx NCPDP Version D.0 Payer Sheet Coupon Voucher

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.

August 1, 2025

RxHighlights - August 2025

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.