FDA News Recap: 5 Approvals to Know from the First Half of 2025

Published on: June 30, 2025

Discover groundbreaking FDA approvals in 2025 that redefine treatment standards, enhance patient care, and address critical public health needs.

The first half of 2025 has unfolded during a period of uncertainty in public health. From ongoing pressure on healthcare systems to workforce shortages and shifting regulatory dynamics, challenges remain on nearly every front. Yet even amid these headwinds, the pace of medical innovation continues—and in some cases, accelerates. The US Food and Drug Administration (FDA) has cleared a series of approvals in 2025 that not only respond to long-standing clinical needs but also redefine what’s possible across multiple therapeutic areas.

This year has already brought forward treatments that could reshape standards of care for millions. From a GLP-1 therapy extending its benefits into kidney disease, to the first new class of non-opioid acute pain relief in over two decades, 2025 has seen approvals that combine clinical impact with public health relevance. Meanwhile, a needle-free option for pediatric anaphylaxis brings greater access and safety, while a new injectable PrEP for HIV prevention promises to dramatically improve adherence. And in dermatology, the first targeted therapy for bullous pemphigoid introduces precision treatment for a historically underserved autoimmune population.

These 5 approvals, listed below in chronological order, stand out not just for their novelty, but for their real-world potential to ease disease burden, improve quality of life, and expand access. In a healthcare environment marked by complexity and rapid change, they are reminders that innovation is still moving forward—sometimes quietly, but decisively.

5 Approvals to Know from the First Half of 2025

1. FDA Approves Semaglutide (Ozempic) for Type 2 Diabetes, Chronic Kidney Disease

Date: January 28, 2025
Indication: Chronic Kidney Disease in Type 2 Diabetes
Company: Novo Nordisk
Summary: On January 28, 2025, Novo Nordisk announced FDA approval of semaglutide (Ozempic) to reduce the risk of kidney disease progression, kidney failure, and cardiovascular death in adults with type 2 diabetes and chronic kidney disease (CKD). Based on the phase 3b FLOW trial, semaglutide reduced the risk of major kidney events by 24% compared to placebo. According to Novo Nordisk, this makes Ozempic the most broadly indicated GLP-1 RA in its class. The trial was stopped early for efficacy, showing additional benefits for cardiovascular outcomes. This approval expands treatment options for millions facing type 2 diabetes with CKD.

2. FDA Approves Suzetrigine, a Non-Opioid Option, for Treatment of Acute Pain

Date: January 30, 2025
Indication: Acute Pain
Company: Vertex Pharmaceuticals
Summary: On January 30, 2025, Vertex Pharmaceuticals announced FDA approval of suzetrigine (Journavx), a first-in-class, non-opioid NaV1.8 pain signal inhibitor for moderate-to-severe acute pain. Based on results from Phase 3 trials in post-surgical patients, suzetrigine significantly reduced pain over 48 hours compared to placebo and showed comparable efficacy to opioids without associated risks like sedation or respiratory depression. According to Vertex, suzetrigine marks the first new pain treatment class approved in over 20 years and offers an effective alternative for opioid-sparing strategies. The therapy was well-tolerated, with most adverse events being mild or moderate. Journavx is contraindicated with strong CYP3A inhibitors and grapefruit products.

3. FDA Approves 1 mg neffy Nasal Spray for Pediatric Anaphylaxis

Date: March 05, 2025
Indication: Type 1 Allergic Reactions
Company: ARS Pharmaceuticals
Summary: On March 5, 2025, ARS Pharmaceuticals announced FDA approval of its 1 mg epinephrine nasal spray (neffy) for children aged 4 and up weighing 15 to under 30 kg for the treatment of type 1 allergic reactions, including anaphylaxis. Based on clinical studies showing comparable efficacy to injectable epinephrine, neffy offers a needle-free alternative that can be administered easily by children and untrained caregivers. According to ARS, this innovation addresses injection hesitancy and improves access and usability in pediatric emergencies. The 1 mg version follows the 2024 approval of the 2 mg formulation for older children and adults.

4. FDA Approves Lenacapavir, First Twice-Yearly HIV Prevention Option

Date: June 18, 2025
Indication: HIV Prevention
Company: Gilead Sciences
Summary: On June 18, 2025, the FDA approved Gilead’s lenacapavir (Yeztugo) as the first twice-yearly injectable PrEP to prevent sexually acquired HIV in individuals aged 12 and up weighing at least 35kg. Based on data from the Phase 3 PURPOSE 1 and 2 trials, lenacapavir showed near-total prevention of HIV transmission, outperforming daily oral alternatives. According to Gilead, lenacapavir could transform HIV prevention by improving adherence and reducing stigma through less frequent dosing. It had a favorable safety profile, with injection site reactions being the most common side effect. This approval marks a major milestone in the fight to end the HIV epidemic.

5. FDA Approves Dupilumab (Dupixent) for Bullous Pemphigoid in Adult Patients

Date: June 20, 2025
Indication: Bullous Pemphigoid
Company: Sanofi/Regeneron
Summary: On June 20, 2025, the FDA approved dupilumab (Dupixent) for treating adults with bullous pemphigoid, marking the first targeted therapy approved for this chronic autoimmune skin disease. Based on the ADEPT trial, dupilumab significantly improved sustained remission and itch reduction compared to placebo while lowering corticosteroid use. According to Sanofi and Regeneron, this expands dupilumab’s reach as a treatment for diseases driven by type 2 inflammation. The therapy blocks IL-4 and IL-13 signaling without broad immunosuppression. This approval adds a new option for the estimated 27,000 U.S. adults with moderate-to-severe bullous pemphigoid.