Innovative Product Approval Showcase: A Quick Mid-Year Roundup
From precision oncology breakthroughs to patient-driven diagnostics, here are some of the FDA’s most impactful approvals of 2025 so far.
Happy Friday! For something a little different heading into the weekend, we’d like to showcase some of the new therapies, medicines, devices, and other products that we feel are particularly innovative and critical.
Some of these products we had the immense pleasure of providing some form of clinical, regulatory, or quality support for during their journey to approval—and we couldn’t be prouder of the teams we’ve worked with and what they’ve accomplished.
This is by no means an exhaustive list. If we’re missing anything you felt was important to call out so far in 2025, leave us a comment or reply to us—we’ll add it!
Small-molecule and other drugs
Vizz (aceclidine) — presbyopia | July 31, 2025
Once-daily miotic that gives near-vision improvement without reading glasses. A fresh entrant into a competitive presbyopia space.Sephience (sepiapterin) — phenylketonuria | July 28–29, 2025
New metabolic pathway approach for PKU. Watch payer policies and adherence in real-world use.Anzupgo (delgocitinib) — chronic hand eczema | July 23, 2025
First topical pan-JAK for CHE in the US—giving dermatologists a targeted option where steroids and calcineurin inhibitors can fall short.Ibtrozi (taletrectinib) — ROS1-positive NSCLC | June 11, 2025
Next-gen ROS1 TKI with CNS activity profile approved for locally advanced/metastatic ROS1+ NSCLC.Ekterly (sebetralstat) — on-demand HAE | July 7, 2025
First and only oral on-demand treatment for hereditary angioedema attacks—a big shift from injectables for acute management.Zusduri (mitomycin hydrogel) — LG-IR NMIBC | June 12, 2025
Office-instilled, sustained-release intravesical chemo. The FDA went against a negative ODAC vote, underscoring unmet need.Widaplik (amlodipine/indapamide/telmisartan) — hypertension | June 5–9, 2025
A single-pill triple therapy to help close the treatment-to-target gap in HTN.Tryptyr (acoltremon) — dry eye disease | May 28, 2025
First-in-class TRPM8 agonist with a novel mechanism for DED symptom relief.
Oncology and advanced therapeutics
Emrelis (telisotuzumab vedotin-tllv) — c-MET-high NSCLC | May 14, 2025
Accelerated approval for the first treatment specifically for NSCLC with high c-MET overexpression (≥50% 3+ IHC). The ADC momentum continues!Zegfrovy (sunvozertinib) — EGFR exon 20ins NSCLC | July 2, 2025
Accelerated approval for meaningful ORR/DOR in post-platinum setting and a companion CDx cleared to speed identification.Lynozyfic (linvoseltamab-gcpt) — RR multiple myeloma | July 2, 2025
BCMA×CD3 bispecific for heavily pretreated adults (≥4 prior lines). It expands options as CAR-T access remains shaky.Monjuvi (tafasitamab-cxix) + lenalidomide + rituximab — FL | June 18, 2025 (new indication)
Adds another chemo-sparing regimen in relapsed/refractory follicular lymphoma.
Infectious diseases and public health
Yeztugo (lenacapavir) — twice-yearly PrEP for HIV | June 18, 2025
First q6-month PrEP. Based on the PURPOSE program showing ≥99.9% remained HIV-negative—huge adherence upside, with access/pricing debates already live.
Rare renal
Fabhalta (iptacopan) — C3 glomerulopathy | March 20–21, 2025
First and only approved therapy for C3G (proteinuria reduction). An oral alternative pathway inhibitor with phase 3 APPEAR-C3G data.
Diagnostics and devices
Fujirebio Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio — blood test for Alzheimer’s | May 16, 2025 (510(k))
First FDA-cleared blood test to aid AD diagnosis in symptomatic adults ≥55. Accelerates workups beyond CSF/PET and is rolling out via national labs.Teal Health “Teal Wand” — at-home self-collection for cervical cancer screening | May 9–15, 2025
First FDA-approved at-home self-collection device enabling HPV-based screening with lab testing. Designed to expand access and adherence.Abbott Tendyne™ — transcatheter mitral valve replacement (TMVR) | PMA decision May 23, notice June 2, 2025
First TMVR approved in the US for severe mitral annular calcification patients not suited for surgery/edge-to-edge repair—major structural heart milestone.
Other
Harliku (nitisinone) — alkaptonuria | June 19
Oral therapy to reduce urinary homogentisic acid.Vostally (ramipril) oral solution — hypertension | July 23/31
Liquid ACE inhibitor to improve dosing flexibility.
Who is The FDA Group?
The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus on Quality Assurance, Regulatory Affairs, and Clinical Operations.
With thousands of resources worldwide, hundreds of whom are former FDA, we meet your precise resourcing needs through a fast, convenient talent selection process supported by a Total Quality Guarantee. Learn more and schedule a call with us to see if we’re a fit to help you access specialized professionals and execute your projects on time and on budget.