Tis’ the season for FDA approvals. The agency has been busy reviewing and approving several new drug candidates before the end of the year, including approvals for the following companies:

• Bayer Global
• Regeneron
• AstraZeneca
• Amgen
• Accord BioPharma

Bayer Global

Bayer Global announced FDA’s approval of Hyrnuo (sevabertinib), an oral reversibly, small molecule, tyrosine kinase inhibitor for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) in adults.¹

The approval follows both priority review and breakthrough drug designation, and was based on objective response rate and duration of response data from the ongoing Phase I/II SOHO-01 trial in patients with advanced NSCLC harboring a HER2-activating mutation, with disease progression after less than one systemic therapy for advanced disease.¹ Continued approval of Hyrnuo’s continued approval for this indication has the potential to be contingent following verification and description of clinical benefit in a confirmatory trial.¹

Regeneron

Regeneron announced the FDA’s approval of two indications of Eylea HD, including an 8mg injection for patients with macular edema following retinal vein occlusion, with up to every eight-week dosing plan, along with a monthly dosing option for patients who may benefit from a monthly dosing schedule.²

Eylea HD’s approval is based on data collected from the Phase III Quasar trial evaluating the efficacy and safety of Eylea HD compared to Eylea (aflibercept) injection 2 mg in patients with RVO.² The trial met its primary endpoint at 36 weeks, with patients who were dosed with Eylea HD every 8 weeks) achieving non-inferior visual acuity gains compared to those receiving Eylea dosed every four weeks.²

AstraZeneca

FDA also sent an approval to AstraZeneca for Koselugo (selumetinib), an oral, selective MEK inhibitor approved for the treatment of adult patients with neurofibromatosis type 1 who have symptomatic, inoperable plexiform neurofibromas.³

Koselugo’s approval was based on positive results from its Phase III trial, Komet, the only placebo-controlled global Phase III trial in a patient population for neurofibromatosis type 1.³ Trial results data was presented at the 2025 American Society of Clinical Oncology Annual Meeting and was also published in The Lancet.³

Amgen

After being granted accelerated approval, FDA announced its full approval of Amgen’s Imdelltra (tarlatamab-dlle) as a treatment for adult patients diagnosed with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.⁴ FDA’s decision to convert Imdelltra's prior accelerated approval to a full approval is based on data from the global Phase III DeLLphi-304 study.⁴

Additionally, updates were made to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology to now include Imdelltra as the only Category 1 preferred treatment option for adult patients with ES-SCLC with disease progression on or after platinum-based chemotherapy.⁴

Accord BioPharma

Additionally, FDA sent Accord BioPharam approvals for both Osvyrti, a biosimilar for Prolia, and Jubereq, a biosimilar to Xgeva, marking the fifth and sixth approved biosimilars for Accord.⁵

Osvytri was approved for treatment in postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, the treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture, to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.⁵

Jubereq was approved to prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.⁵

Sources

1. U.S. FDA grants accelerated approval to Bayer’s HYRNUO™ (sevabertinib) for patients with previously treated advanced HER2-mutant non-small cell lung cancer Bayer Global November 20, 2025 https://www.bayer.com/media/en-us/us-fda-grants-accelerated-approval-to-bayers-hyrnuo-sevabertinib-for-patients-with-previously-treated-advanced-her2-mutant-non-small-cell-lung-cancer/
2. EYLEA HD® (aflibercept) Injection 8 mg Approved by FDA for the Treatment of Macular Edema Following Retinal Vein Occlusion (RVO) and for Monthly Dosing Across Approved Indications Regeneron November 19, 2025 https://investor.regeneron.com/news-releases/news-release-details/eylea-hdr-aflibercept-injection-8-mg-approved-fda-treatment
3. Koselugo approved in the US for adults with neurofibromatosis type 1 AstraZeneca Novmeber 20, 2025 https://www.astrazeneca.com/media-centre/press-releases/2025/koselugo-selumetinib-approved-in-the-us.html
4. FDA Grants Full Approval to Amgen’s Imdelltra in Extensive Stage Small Cell Lung Cancer Amgen Novmeber 19, 2025 https://www.amgen.com/newsroom/press-releases/2025/11/fda-grants-full-approval-to-amgens-imdelltra-in-extensive-stage-small-cell-lung-cancer
5. Accord BioPharma, Inc. Announces FDA Approval of Denosumab Biosimilars OSVYRTI® (denosumab-desu) and JUBEREQ® (denosumab-desu) Accord BioPharma November 20, 2025 https://www.prnewswire.com/news-releases/accord-biopharma-inc-announces-fda-approval-of-denosumab-biosimilars-osvyrti-denosumab-desu-and-jubereq-denosumab-desu-302621107.html