Lunsumio Velo for Subcutaneous Use Approved in Follicular Lymphoma

On Dec. 22, 2025, the US Food and Drug Administration (FDA) approved Roche’s Lunsumio Velo^™(mosunetuzumab), a new subcutaneous (SC) formulation of Lunsumio for the treatment of adult patients who have relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. The CD20xCD3 bispecific antibody enables administration via a one-minute injection, reducing treatment time compared to the previous two-to-four-hour intravenous (IV) infusion. Approval was based on results from the phase I/II study, which showed an objective response rate of 75% and a complete response rate of 59%, with a median duration of response of 22.4 months. Like the IV version, Lunsumio Velo can be given in outpatient settings as a fixed-duration therapy, often completed in about six months, unlike treat-to-progression options that continue indefinitely until disease worsens or treatment becomes intolerable. Lunsumio Velo received accelerated approval. Launch and cost are not yet known. The prescribing information can be found here. 

FDA Approves Jascayd for Progressive Pulmonary Fibrosis

On Dec. 19, 2025, the FDA granted another indication to Boehringer Ingelheim’s Jascayd^®(nerandomilast) tablets for the treatment of adults who have progressive pulmonary fibrosis (PPF), following its earlier approval for idiopathic pulmonary fibrosis (IPF). PPF affects up to 100,000 people in the US. It often develops from underlying interstitial lung diseases, environmental exposures or unknown causes, and can lead to declining lung function. Jascayd is the first preferential phosphodiesterase 4B (PDE4B) inhibitor with immunomodulatory and antifibrotic effects, offering a novel oral therapy for this debilitating condition. Approval was based on the phase III FIBRONEER-ILD trial, which showed Jascayd significantly slowed lung function decline in 1,178 adults with PPF, reducing the average forced vital capacity (FVC) loss to -72 mL and -85 mL with 18 mg and 9 mg doses, respectively, versus -151 mL with placebo at 52 weeks. Patients on Jascayd also had fewer exacerbations, respiratory hospitalizations or deaths. The recommended dose is 9mg or 18mg twice daily. Here is the updated prescribing information.

Fesilty Approved for Congenital Fibrinogen Deficiency

The FDA approved Grifols’ Fesilty™ (fibrinogen, human-chmt) on Dec. 19, 2025, for the treatment of acute bleeding episodes in pediatric and adult patients who have congenital fibrinogen deficiency (CFD), including hypo- or afibrinogenemia. CFD is a rare inherited disorder caused by genetic mutations that impair the production or function of fibrinogen, a liver-produced plasma protein essential for blood clotting and wound healing. Low fibrinogen levels hinder the body’s ability to control bleeding, especially during acute bleeding episodes. Treatment for low fibrinogen levels includes fresh frozen plasma, cryoprecipitate or fibrinogen concentrate. Fesilty is a highly purified fibrinogen concentrate that enables rapid and predictable restoration of fibrinogen levels, offering an alternative to cryoprecipitate or fresh frozen plasma, which require large infusion volumes. Approval was based on clinical data demonstrating effective control of bleeding and a favorable safety profile. The recommended dose is individualized based on body weight and target fibrinogen levels, administered IV. Fesilty carries standard precautions for plasma-derived products and will be available in the US during the first half of 2026. The prescribing information is here. 

FDA Approves First Oral Iron Therapy for Pediatric Patients

On Dec. 22, 2025, the FDA approved Shield Therapeutics’ Accrufer^® (ferric maltol) capsules for the treatment of iron deficiency in pediatric patients ages 10 years and older. Previously approved for adults in 2019, this oral therapy offers a convenient alternative to IV iron, addressing the most common cause of anemia. Approval was supported by the FORTIS trial, which demonstrated a clinically meaningful average hemoglobin increase of 1.1g/dL at week 12 in 24 patients, comparable to the effect of one blood transfusion. The recommended dose is 30mg orally twice daily on an empty stomach, one hour before or two hours after meals. Capsules should be swallowed whole without opening, breaking, or chewing. Therapy should continue until iron stores are replenished. Common side effects include flatulence, diarrhea, constipation, and abdominal discomfort. Here is the updated prescribing information.

More Denosumab Biosimilars Approved

On Dec. 22, 2025, the FDA approved Amneal’s Boncresa^™ (denosumab-mobz) and Oziltus^™(denosumab-mobz), biosimilars to Prolia^® and Xgeva^® respectively, for the treatment of osteoporosis and skeletal-related events in cancer patients. Boncresa is indicated for the treatment of osteoporosis for those at high risk for fracture in certain populations like men, post-menopausal women and those taking glucocorticoids or certain drugs for prostate and breast cancer. It is administered by a healthcare provider as a 60mg SC injection once every six months. Oziltus is indicated to prevent skeletal-related events for some patients who have multiple myeloma, bone metastases from solid tumors, giant cell tumors of the bone or hypercalcemia of malignancy. After loading doses, it is administered as a 120mg SC injection once monthly by a healthcare provider. Approval was granted under Amneal’s partnership with mAbxience, which manages development and manufacturing, while Amneal holds commercialization rights. Jubbonti^® (denosumab-bbdz – Sandoz), the first biosimilar to Prolia, and Wyost^® (denosumab-bbdz – Sandoz), the first biosimilar to Xgeva, launched on May 31, 2025.

Third Interchangeable Lucentis Biosimilar Approved 

The FDA approved Formycon AG’s Nufymco^® (ranibizumab-leyk) as an interchangeable biosimilar to Lucentis^® (Genentech/Novartis) on Dec. 18, 2025. Indicated for the treatment of wet age-related macular degeneration, diabetic macular edema, diabetic retinopathy, macular edema following retinal vein occlusion, and myopic choroidal neovascularization, the Vascular Endothelial Growth Factor (VEGF) inhibitor is administered via intravitreal injection (6mg/mL and 10mg/mL). Cimerli^®(ranibizumab-ranq – Sandoz/Bioeq) and Byooviz^® (ranibizumab-nuna – Samsung Bioepis/Biogen) are interchangeable Lucentis biosimilars available on the market. According to IQVIA, the total addressable market opportunity for ranibizumab biosimilars in the US is approximately $210 million.

Aqvesme Approved for Thalassemia Related Anemia

On Dec. 23, 2025, the FDA approved Aqvesme^™ (mitapivat – Agios) oral tablets for the treatment of anemia in adults who have alpha- or beta-thalassemia, including both non–transfusion dependent and transfusion dependent patients. Mitapivat is an activator of pyruvate kinase that enhances glycolytic activity and improves red blood cell energy metabolism. Approval was based on the ENERGIZE and ENERGIZE-T phase III trials, which demonstrated clinically meaningful hemoglobin increases and transfusion burden reduction with 42.3% of patients achieving increased hemoglobin and 30.4% achieving 50% or more transfusion reduction compared to placebo. The recommended dose is 100mg orally twice daily with food. Common adverse reactions include headache and insomnia. Aqvesme has a boxed warning and a Risk Evaluation and Mitigation Strategy (REMS) program is in place to monitor liver safety. US availability is expected in late January 2026. Mitapivat is also marketed by Agios as Pyrukynd^® for adults who have pyruvate kinase deficiency, approved in 2022, making Aqvesme the second indication for this product under a new trade name. Here is the prescribing information.