Webinar | Is Your Packaging PPWR Ready? Register Here

Explore the FDA’s 2025 Drug Approvals: What Got Approved, When, and for What

Authors

Project Manager

In 2025, the FDA has approved 28 new therapies, each signaling how the next decade of pharma innovation and IP strategy will unfold. From oncology and rare diseases to quality-of-life treatments, these approvals mark a shift from chasing blockbusters to building precision-driven, defensible markets.

Key Therapeutic Forces Reshaping the 2025 Pipeline

Oncology:

Cancer remains the top area for innovation, with nearly a dozen approvals. Lung cancer alone saw four targeted drugs – Emrelis, Ibtrozi, Zegfrovy, and Hernexeos, each designed for distinct biomarkers such as c-Met, ROS1, EGFR exon 20, and HER2 mutations.

Companies are creating molecular niches, protecting them with specialized IP, and avoiding direct competition.

Hematology:

Approvals like Lynozyfic (multiple myeloma) and Grafapex (transplant preparation) demonstrate a shift toward vertical integration within oncology, utilizing shared expertise to expand across treatment stages and strengthen long-term market control.

Rare Diseases:

Three approvals, Andembry, Ekterly, and Dawnzera, target hereditary angioedema through different mechanisms. Alongside Sephience (PKU) and Gomekli (neurofibromatosis type 1), they highlight a key trend: capturing dominant share in ultra-rare conditions often delivers higher margins than competing in crowded markets.
Orphan exclusivities, fast-track pathways, and smaller patient bases are driving a refined IP and commercialization approach.

List of Drugs Approved by the FDA in 2025

Therapeutic AreaDrugs (Brand Name)Active IngredientsApproval DateFDA-approved use
Oncology – Lung CancerEmrelistelisotuzumab vedotin-tllv5/14/2025To treat locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression after prior systemic therapy
Ibtrozitaletrectinib6/11/2025To treat locally advanced or metastatic ROS1-positive non-small cell lung cancer
Zegfrovysunvozertinib7/2/2025To treat locally advanced or metastatic non-small cell lung cancer with epidermal growth factor factor exon 20 insertion mutations, as detected by an FDA-approved test, with disease progression on or after platinum-based chemotherapy
Hernexeoszongertinib8/8/2025To treat adults with unresectable or metastatic non-squamous non-small cell lung cancer whose tumors have HER2 tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy
Oncology – Breast CancerDatrowaydatopotamab deruxtecan-dlnk1/17/2025To treat unresectable or metastatic, HR-positive, HER2-negative breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease
Oncology – Hematology / Multiple MyelomaLynozyficlinvoseltamab-gcpt7/2/2025To treat relapsed or refractory multiple myeloma after at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti CD38 monoclonal antibody
Oncology – Hematology / Transplant PrepGrafapextreosulfan1/21/2025For use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation for acute myeloid leukemia and myelodysplastic syndrome
Oncology – Rare Tumors / OtherGomeklimirdametinib2/11/2025To treat neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection
Romvimzavimseltinib2/14/2025To treat symptomatic tenosynovial giant cell tumor for which surgical resection will potentially cause worsening functional limitation or severe morbidity
penpulimab-kcqxpenpulimab-kcqx4/23/2025In combination with either cisplatin or carboplatin and gemcitabine, to treat adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC), or as a single agent while on or after platinum-based chemotherapy and at least one other prior line of therapy
Avmapki Fakzynja Co-Packavutometinib + defactinib5/8/2025To treat KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) after prior systemic therapy
Modeysodordaviprone8/6/2025To treat diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy
Immunology / Rare DiseaseAndembrygaradacimab-gxii6/16/2025To prevent attacks of hereditary angioedema
Ekterlysebetralstat7/3/2025To treat acute attacks of hereditary angioedema
Dawnzeradonidalorsen8/21/2025To prevent attacks of hereditary angioedema
Hematology / CoagulationQfitliafitusiran3/28/2025To prevent or reduce the frequency of bleeding episodes in hemophilia A or B
Hematology / AutoimmuneWayrilzrilzabrutinib8/29/2025To treat persistent or chronic immune thrombocytopenia that has not sufficiently responded to immunoglobulins, anti-D therapy, or corticosteroids
Neurology – AutoimmuneImaavynipocalimab-aahu4/29/2025To treat generalized myasthenia gravis
Pain Management / AnalgesicJournavxsuzetrigine1/30/2025To treat moderate to severe acute pain
NephrologyVanrafiaatrasentan4/2/2025To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression
DermatologyAnzupgodelgocitinib7/23/2025To treat moderate-to-severe chronic hand eczema when topical corticosteroids are not advisable or produce an inadequate response
Metabolic Disorders / PediatricsSephiencesepiapterin7/28/2025To treat hyperphenylalaninemia in patients with sepiapterin-responsive phenylketonuria, in conjunction with a phenylalanine-restricted diet
OphthalmologyTryptyracoltremon5/28/2025To treat the signs and symptoms of dry eye disease
Vizzaceclidine7/31/2025To treat presbyopia
Pulmonology / RespiratoryBrinsupribrensocatib8/12/2025To treat non-cystic fibrosis bronchiectasis
Anti-infective / UrologyBlujepagepotidacin3/25/2025To treat uncomplicated urinary tract infections
Infectious Disease / PediatricsEnflonsiaclesrovimab-cfor6/9/2025To prevent respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants who are born during or entering their first RSV season

The 2025 approval landscape reflects a clear shift in how competitive advantage is being built in pharma. Success now lies in identifying smaller, high-value patient segments and protecting them through targeted IP strategies. 

Companies are using regulatory flexibility, such as orphan designations and accelerated approvals, to secure early market entry and prolonged exclusivity. For IP and strategy teams, the opportunity lies in tracking how these approvals reshape therapeutic boundaries, where each new molecule doesn’t just treat disease but defines a new market.

And that’s where drug tracking tools like Elixir can be of help!

Explore FDA exclusivities and next-wave drug launches on Elixir


Share This Article:

Authors

Project Manager

Related Articles

Table of Contents

More Curated Insights For You

Facing A Roadblock On Your Project?

Our Experts Are Here To Help.