By June 30, the U.S. Food and Drug Administration (FDA) had approved 16 new molecular entities (NMEs), including 9 small-molecule drugs and 7 biologics. Notably, 8 of these were first-in-class medicines—therapies based on entirely new mechanisms of action.

Table. FDA Approves 16 Innovative Drugs in H1 2025

This trend underscores the industry’s shift toward precision medicine, with a strong focus on unmet needs in oncology, infectious disease, and rare disorders, etc.

Two Antibody-Drug Conjugates (ADCs) Approved

Among the most significant developments in early 2025 were two key approvals in the field of antibody-drug conjugates (ADCs)—targeted cancer therapies that combine monoclonal antibodies with potent cytotoxic agents. These approvals are reshaping the treatment landscape for solid tumors with limited therapeutic options.

Datroway (datopotamab deruxtecan)

Approved for:

• • HR-positive, HER2-negative breast cancer

• • EGFR-mutated non-small cell lung cancer (NSCLC)

Co-developed by Daiichi Sankyo and AstraZeneca, Datroway represents a new generation of TROP2-targeting ADCs. It links a TROP2-directed antibody to a topoisomerase I inhibitor payload (DXd) via a cleavable linker. The drug was approved first for metastatic HR+/HER2− breast cancer in January and later, in June, for patients with EGFR-mutated NSCLC who have progressed on targeted therapy and chemotherapy.

Datroway enters a competitive space, especially in breast cancer, but may hold greater long-term value in lung cancer—a market with high unmet need. Its design, supported by robust clinical evidence, makes it one of the most commercially promising ADCs of 2025, with projected global sales exceeding $5.9 billion by 2030 from Evaluate.

Emrelis (telisotuzumab vedotin)

Approved for: c-Met overexpressing non-squamous NSCLC

Developed by AbbVie, Emrelis is a first-in-class c-Met-directed ADC comprising of a c-Met-binding antibody, cleavable linker and the monomethyl auristatin E (MMAE) payload. It was granted accelerated approval in May for adult patients with c-Met–overexpressing NSCLC after prior systemic treatment. The therapy builds on years of research into c-Met as a biomarker and lays the groundwork for future trials, including an ongoing global Phase 3 study (TeliMETNSCLC-01).

Both approvals highlight the rapid clinical momentum behind ADCs. According to market research by Frost & Sullivan, the global ADC market is expected to double by 2030, reaching approximately $66.2 billion.

Seven First-in-Class Approvals

In addition to ADCs, several newly approved first-in-class drugs are reshaping standards of care across a broad range of diseases.

Journavx (suzetrigine)

• • Indication: Acute moderate-to-severe pain

• • Developer: Vertex Pharmaceuticals

Journavx, approved in January, is the first oral non-opioid analgesic in decades. It selectively inhibits NaV1.8 voltage-gated sodium channels, offering pain relief without the risks of dependence and tolerance associated with opioids. While approved for acute pain, its potential in chronic pain is under evaluation.

Blujepa (gepotidacin)

• • Indication: Uncomplicated urinary tract infections

• • Developer: GSK

Approved in March, Blujepa is the first new class of oral antibiotic for urinary tract infections in over 30 years. It exerts dual inhibition on bacterial topoisomerase enzymes (GyrB and ParE), making it effective against resistant strains and reducing the likelihood of resistance development.

Qfitlia (fitusiran)

• • Indication: Hemophilia A and B (with or without inhibitors)

• • Developers: Sanofi & Alnylam

Qfitlia, approved in March, is an siRNA therapy that lowers antithrombin production, restoring thrombin generation to reduce bleeding in patients with hemophilia A or B. Delivered subcutaneously, it’s the first RNAi treatment approved for both hemophilia types regardless of inhibitor status.

Imaavy (nipocalimab)

• • Indication: Generalized myasthenia gravis (gMG)

• • Developer: Johnson & Johnson

Approved in April, Imaavy is a monoclonal antibody targeting the neonatal Fc receptor (FcRn). By interfering with the binding of IgG to FcRn, IMAAVY increases the lysosomal degradation of IgG and blocks IgG recycling, which reduces serum levels of total IgG and pathogenic IgG autoantibodies and alloantibodies that underlie multiple disease states. Its clinical program spans multiple autoimmune diseases, with several additional indications under accelerated review.

Avmapki Fakzynja Co-pack

• • Indication: KRAS-mutant low-grade serous ovarian cancer (LGSOC)

• • Developer: Verastem Oncology

AVMAPKI FAKZYNJA CO-PACK, approved by the FDA in May, is a novel combination of AVMAPKI (avutometinib capsules, a MEK1 inhibitor) and FAKZYNJA (defactinib tablets, a FAK inhibitor). This combination was designed to provide a more complete blockade of the signaling that drives the growth and drug resistance of RAS/MAPK pathway-dependent tumors. It is the first and only FDA-approved medicine for this KRAS-mutated recurrent LGSOC.

Tryptyr (acoltremon)

• • Indication: Dry eye disease (DED)

• • Developer: Alcon

Tryptyr, approved in May, is a TRPM8 receptor agonist that stimulates natural tear production by activating corneal sensory nerves. Phase 3 trials showed rapid and sustained improvements in tear secretion, addressing an important need in dry eye management.

Andembry (garadacimab)

• • Indication: Hereditary angioedema (HAE) prophylaxis

• • Developer: CSL Behring

Approved in June, Andembry is the first factor XIIa (FXIIa) inhibitor approved for preventing HAE attacks. By blocking FXIIa, it prevents prekallikrein activation to kallikrein and reduces bradykinin generation, thereby preventing the inflammatory cascade causing HAE attacks. Its once-monthly subcutaneous dosing and broad international approvals make it a highly anticipated therapy.

Looking Ahead

The first half of 2025 demonstrates how cutting-edge science is increasingly translating into real-world treatments. ADCs are gaining traction in solid tumors, while novel drug platforms—such as siRNA, FcRn inhibitors, and ion channel modulators—are pushing therapeutic boundaries.

As more first-in-class candidates move through the pipeline, we can expect an even more dynamic second half of the year, with new therapies offering hope to patients across cancer, rare disease, infection, and beyond.

References:
[1] Novel Drug Approvals for 2025. Retrieved June 20, 2025, from https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025
[2] Global Oncology Trends 2025. Retrieved June 24, 2025, from https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/global-oncology-trends-2025