What dosage forms are leading the way among new drug approvals thus far in 2025? DCAT Value Chain Insights examines the key trends and latest developments in drug delivery and drug-product development and manufacturing.  

By Patricia Van Arnum, Editorial Director, DCAT, pvanarnum@dcat.org

New drug approvals & dosage forms
For CDMOs/CMOs providing formulation development and drug-product manufacturing, important indicators to look at are trends in new drug approvals and the related dosage forms of these products. In looking at new drug approvals thus far in 2025 and the dosage forms/route of administration for those drugs, there was a fairly balanced distribution between dosage forms with oral drug delivery and dosage forms with non-oral drug delivery. Through July 31, 2025, FDA’s Center for Drug Evaluation and Research had approved 22 new molecular entities and biological therapeutics. Of these 22 new drug approvals, nine are drugs delivered via injections, infusions, or subcutaneously, 10 new drugs are delivered orally (tablet, capsule, or powder for oral delivery), two drugs were solutions/drops for ophthalmic use, and one product was a cream for topical drug delivery (see Table I at the end of the article).

New drugs delivered via injections, infusions or subcutaneously included AbbVie’s Emrelis (telisotuzumab vedotin-tllv), an antibody drug conjugate (ADC) for treating locally advanced or metastatic, non-squamous non-small cell lung cancer and AstraZeneca/Daiichi Sankyo’s Datroway (datopotamab deruxtecan-dlnk), an ADC for treating unresectable or metastatic, HR-positive, HER2-negative breast cancer. Also gaining approval was Johnson & Johnson’s Imaavy (nipocalimab-aahu) for treating generalized myasthenia gravis, Merck & Co.’s Enflonsia (clesrovimab-cfor) for treating respiratory syncytial virus-based lower respiratory tract disease in neonates and infants, and Sanofi’s Qfitlia (fitusiran) for preventing or reducing the frequency of bleeding episodes in hemophilia A or B.

Among mid-sized companies with new drug approved delivered via injections, infusions or subcutaneously included CSL Behring’s Andembry (garadacimab-gxii) for treating hereditary angioedema and Regeneron Pharmaceuticals’ Lynozyfic (linvoseltamab-gcpt) for treating relapsed or refractory multiple myeloma.

Among smaller companies with new drug approved delivered via injections, infusions or subcutaneously are Akeso’s penpulimab-kcqx (penpulimab-kcqx) for treating recurrent or metastatic non-keratinizing nasopharyngeal carcinoma and Medexus’ Grafapex (treosulfan), a preparative regimen for allogeneic hematopoietic stem cell transplantation for acute myeloid leukemia and myelodysplastic syndrome.

Specialty dosage forms among the new drugs approved thus far in 2025 included: Alcon’s Tryptyr (acoltremon ophthalmic solution) for treating dry-eye disease and Lenz Therapeutics’ Vizz (aceclidine ophthalmic solutions) for treating presbyopia, a gradual loss of the eye’s ability to focus on near objects. LEO Pharma also received approval for Anzupgo (delgocitinib), a cream delivered topically for treating moderate-to-severe chronic hand eczema.

New drug approvals and oral drug delivery
Among the larger pharmaceutical companies with new drugs for oral delivery included GlaxoSmithKline’s Blujepa (gepotidacin) for teating noncomplicated urinary tract infections, Merck KGaA’s Gomekli (mirdametinib) for treating neurofibromatosis Type 1, and Novartis’ Vanrafia (atrasentan) for treating proteinuria in adults with primary  immunoglobulin A nephropathy.

Other companies with new products approved thus far in 2205 with oral drug delivery include Dizal (Jiangsu) Pharmaceutical with Zegfrovy (sunvozertinib) for treating certain forms of locally advanced or metastatic non-small cell lung cancer and Nuvation Bio with Ibtrozi (taletrectinib) for treating locally advanced or metastatic ROS1-positive non-small cell lung cancer. Other approvals of products for oral drug delivery included: Kalvista Pharmaceuticals’ Ekterly (sebetralstat) for treating acute attacks of hereditary angioedema; Ono Pharmaceutical’s Romvimza (vimseltinib) for treating symptomatic tenosynovial giant cell tumor; PTC Therapeutics’ Sephience (sepiapterin) for treating hyperphenylalaninemia in patients with sepiapterin-responsive phenylketonuria, in conjunction with a phenylalanine-restricted diet; Verastem’s Avmapki Fakzynja Co-Pack (avutometinib and defactinib) for treating KRAS-mutated recurrent low-grade serous ovarian cancer after prior systemic therapy; and Vertex Pharmaceuticals’ Journavx (suzetrigine) for treating moderate-to-severe acute pain.