FDA Recent Approvals of Innovative Medicine Products

The FDA has recently approved a series of innovative drugs and devices, mainly including ophthalmology, oncology, orphan drugs, infectious diseases, and diagnostic devices.

Small Molecules and Other Drugs

• Vizz: Presbyopia (July 31, 2025)

A once-daily miotic that is administered topically to improve near vision, with the prospect of eliminating the need for reading glasses. This product is a new contender in entering the competitive presbyopia treatment market.

• Sephience: Phenylketonuria (PKU) (July 28 - 29, 2025)

Use a novel metabolic pathway to treat PKU. Further development requires attention to medical insurance reimbursement policies and patient adherence in the real world.

• Anzupgo: Chronic Hand Eczema (July 23, 2025)

The first topical pan-JAK inhibitor available in the United States for the treatment of chronic hand eczema, offering a new option for some patients who do not respond to treatment with corticosteroids or calcineurin inhibitors.

• Ibtrozi: ROS1-Positive Non-Small Cell Lung Cancer (June 11, 2025)

An indication for a second-generation ROS1 targeted therapy with CNS activity, for patients with locally advanced or metastatic ROS1-positive disease.

• Ekterly: Acute Attacks of Hereditary Angioedema (HAE) (July 7, 2025)

The world's first oral on-demand treatment, providing a more convenient option than injection for the management of acute attacks.

• Zusduri: Low-Grade Intermediate-Risk Bladder Cancer (June 12, 2025)

An office-administered sustained-release intravesical chemotherapy. The FDA's approval, despite opposition from its advisory committee, highlights an urgent clinical need.

• Widaplik: Hypertension (June 5 - 9, 2025)

A triple-combination pill combining three anti-hypertensive components helps more patients achieve their blood pressure control targets.

• Tryptyr: Dry Eye Disease (May 28, 2025)

The world's first TRPM8 receptor agonist, relieving dry eye symptoms through a novel mechanism.

Oncology and Advanced Therapies

• Emrelis (telisotuzumab vedotin-tllv): c-MET High-Expressed Non-Small Cell Lung Cancer (NSCLC) (May 14, 2025)

The first therapeutic drug specifically targeting c-MET high-expressing NSCLC received accelerated approval, continuing the Antibody-Drug Conjugate (ADC) development trend.

• Zegfrovy: EGFR Exon 20 Insertion Mutation NSCLC (July 2, 2025)

Indicated for patients following platinum-based chemotherapy, significantly improving response rate and duration of response, with the simultaneous launch of a companion diagnostic to accelerate patient selection.

• Lynozyfic: Relapsed/Refractory Multiple Myeloma (July 2, 2025)

BCMA × CD3 bispecific antibody for patients who have received multiple lines of therapy but have limited treatment options. A new alternative to CAR-T therapy.

• Monjuvi Combination Regimen: Follicular Lymphoma (June 18, 2025)

The approval of the new indication will provide another chemotherapy-free treatment combination for patients with relapsed or refractory disease.

Infectious Diseases and Public Health

• Yeztugo: Once-Every-Six-Month HIV Prevention (June 18, 2025)

A once-every-six-month PrEP (Pre-Exposure Prophylaxis) regimen. The trial reduced the risk of infection to near zero, with a significant improvement in adherence. The controversial issue remains price and accessibility.

Rare Kidney Diseases

• Fabhalta: C3 Glomerulopathy (C3G) (March 20 - 21, 2025)

The first and only approved treatment for C3G, which significantly reduces proteinuria and acts as an oral alternative inhibitor.

Diagnostics and Devices

• Fujirebio Lumipulse G Blood Test: Alzheimer's Disease (May 16, 2025)

The first FDA-approved blood test in the US for Alzheimer's disease diagnosis, indicated for symptomatic patients aged 55 and older, which can significantly expedite the diagnostic process.

• Teal Wand Home Cervical Cancer Screening Kit: Cervical Cancer (May 9 - 15, 2025)

The first FDA-approved HPV home self-collection device, which helps increase screening coverage.

• Abbott Tendyne™ Mitral Valve Replacement (Approved May 23, announced June 2, 2025)

The first transcatheter mitral valve replacement (TMVR) solution in the United States was approved for use in patients who are not candidates for surgery or other repair methods. A milestone for structural heart disease.

Other

• Harliku: Alkaptonuria (AKU) (June 19, 2025)

An oral medication that reduces high levels of homogentisic acid in the urine.

• Vostally Oral Solution: Hypertension (July 23/31, 2025)

A liquid formulation of an ACE inhibitor, allowing for easier dose adjustment.

Disclaimer: The above content is compiled based on existing public information and is for reference only.

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