5 FDA Approval Categories In 2025
By Katie Anderson, Chief Editor, Pharmaceutical Online
The FDA’s Center for Drug Evaluation and Research (CDER) approved 46 novel drugs in 2025, down from 50 new drugs approved in 2024 and 55 in 2023. Though a reduction of novel drugs is never anything we want to see, given the turnover in leadership at the FDA in 2025, five less approvals seem like not a big deal.
Importantly, 34 of the 46 drugs approved by CDER in 2025 were small molecule. With less drugs approved in 2025, it is interesting to see what drugs made it through and if any categories of treatment emerged. Of those approved in 2025, the reigning category of approvals were those for cancer, though there were also quite a few approvals for cardiovascular issues, angioedema, women’s health, and blood disorders.
Oncology Approvals
There were 14 drugs approved by the FDA for the treatment of various cancers.
Five drugs were approved for the treatment of non small cell lung cancer, including four small molecule drugs and one antibody drug conjugate. Both Hyrnuo and Hernexeos are small molecule treatments for non-squamous, non-small cell lung cancer whose tumors have HER2 tyrosine kinase domain activating mutations. While Hernexeos is geared toward unresectable or metastatic non-squamous, non-small cell lung cancer, Hyrnuo is designed for locally advanced or metastatic non-squamous, non-small cell lung cancer. Ibtrozi, Zegfrovy and Emrelus also address locally advanced or metastatic non-small cell lung cancer, Ibtrozi focused on ROS-1, Zefrovy focused on epidermal growth factor receptor exon 20 insertion mutations, and Emrelus focused on high c-Met protein overexpression after prior systemic therapy.
Both Datroway and Inlurio are treatments for breast cancer; Datroway being an ADC treatment for unresectable or metastatic, HR-positive, HER2-negative breast cancer who have received prior endocrine-based therapy and chemotherapy and Inlurio being a small molecule treatment for estrogen receptor-positive, human epidermal growth factor receptor 2-negative, estrogen receptor-1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. Approved for ovarian cancer was Avmapki Fakzynja Co-Pack, specifically for KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) after prior systemic therapy.
Other approved cancer therapies included: Grafapex and Komzifti for acute myeloid leukemia; Keytruda Qlex for faster, subcutaneous treatment of solid tumors, Modeyso for the aggressive brain tumor diffuse midline glioma harboring an H3 K27M mutation; Lynzific for multiple myeloma; and penpulimab-kcqx for nasopharyngeal carcinoma.
Hereditary Angioedema Drugs
Three novel drugs were approved in 2025 for the treatment of hereditary angioedema (HAE). So, why three drugs for the same condition in 2025? Though the condition is rare (1 in 50,000), there was a lack of treatments for the potentially life-threatening genetic condition.
Both Andembry and Dawnsera were designed to prevent attacks in HAE, both through injection. Dawnsera targets mRNA to reduce the protein (prekallikrein) that causes the dangerous swelling in HAE. Andembry targets a different protein (xlla) involved in the progression of HAE swelling. Ektery is a small molecule treatment designed to reduce acute attacks in HAE by inhibiting the plasma protein killikrein.
Blood Disorders
There were four treatments approved in 2025 for the treatment of blood disorders.
As previously mentioned, both Komzifti and Grafapex were approved for the treatment of acute myeloid leukemia. While Komzifti treats relapsed or refractory acute myeloid leukemia with a susceptible necleophosmin 1 mutation, Grafapex prepares those with acute myeloid leukemia for allogeneic hematopoietic stem cell transplantation.
Also approved for hematopoietic stem cell transplant was biologic Yartemlea, which treats thrombotic microangiopathy. Wayrilz was approved to treat chronic immune thrombocytopenia, and Qfitlia was approved to reduce bleeding in hemophilia A or B.
Cardiac Drug Approvals
There were five drugs approved in 2025 to address cardiac diseases.
For obstructive hypertrophic cardiomyopathy, Myqorzo was approved. Acoramidis was approved in early 2025 to reduce negative outcomes in those with transthyretin amyloid cardiomyopathy.
Though Barth syndrome isn’t a cardiac disease, it often has associated cardiomyopathy. For that reason, I am mentioning Elamipretide here, which was approved to improve muscle strength in Barth syndrome.
Cardamyst was approved as the first nasal mist to treat episodes of paroxysmal supraventricular tachycardia, and Lerochol was approved to reduce LDL in adults with hypercholesterolemia.
Women’s Health Approvals
Last, but certainly not least, there were five drugs approved to treat female health conditions. As previously mentioned, both Datroway and Inluriyo were approved for breast cancer treatment and Avmapki Fakzynja was approved for the treatment of ovarian cancer.
Lynkuet is an approved oral drug for the treatment of hot flashes due to menopause, and Blujepa opened up a new antibiotic class with a female indication when it was approved for the treatment of urinary tract infections in females over the age of 12.
A Forward Look at 2026
Though these drug categories saw more approval than others, there were a number of other notable novel drug approvals in 2025.
For example, the FDA approved Nuzolvence for the treatment of gonorrhea in patients 12 years and older. Importantly, Nuolvence is a first antibiotic of its kind and a welcome alternative to injectable treatments.
Vizz was also approved for the treatment of age-related loss of near vision. The drops are said to improve near vision for up to 10 hours. Enflonsia is an injectible monoclonal antibody approved to prevent severe RSV in infants.
There has been one novel drug approved so far in 2026, but with all the new FDA programs designed to bring important medicines to market faster, it is fair to be optimistic that 2026 may see as many novel approvals as 2025, if not more.