MedPath

Tagged News

FDA Approves Updated AIRSUPRA Label Showing 46% Reduction in Asthma Attacks for Mild Asthma Patients

Drug Approval
  • The FDA has approved an updated label for AIRSUPRA (albuterol/budesonide) that includes evidence from the BATURA Phase IIIb trial demonstrating a 46% reduction in severe asthma exacerbations compared to albuterol alone in mild asthma patients.
  • The BATURA trial enrolled 2,421 participants and showed AIRSUPRA significantly reduced the risk of severe exacerbations with a hazard ratio of 0.54 (95% CI: 0.40, 0.72; p<0.001) over 12-52 weeks of treatment.
  • AIRSUPRA represents the first and only anti-inflammatory rescue medication approved in the US, combining albuterol with budesonide to address both symptoms and underlying inflammation in asthma patients aged 18 and older.
  • The label update aligns with 2025 Global Initiative for Asthma (GINA) recommendations supporting anti-inflammatory rescue approaches across all asthma severities, moving away from SABA-only treatments.

A Comparison of PT027 vs PT007 Used as Needed in Participants With Asthma

NCT05505734CompletedPhase 3
Bond Avillion 2 Development LP
Posted 9/2/2022

CARsgen's Zevor-cel Shows Exceptional 5-Year Survival Data in Relapsed Multiple Myeloma Patients

CAR-TDrug Approval
  • CARsgen presented updated long-term follow-up results for zevor-cel at the International Myeloma Society Annual Meeting, showing a 100% overall response rate in 14 relapsed/refractory multiple myeloma patients.
  • The BCMA-targeting CAR T-cell therapy demonstrated exceptional durability with median progression-free survival of 44.1 months and one patient remaining in stringent complete response at 59.3 months.
  • Safety profile remained manageable with no Grade 3 or higher cytokine release syndrome, neurotoxicity, or delayed adverse events reported during the 53.3-month median follow-up period.
  • Survival rates at 24, 36, 48, and 60 months post-infusion were 100%, 92.3%, 84.6%, and 76.9% respectively, with median overall survival not yet reached.

NICE Approves Durvalumab for Limited-Stage Small Cell Lung Cancer, First Treatment Advance in Over 30 Years

Drug Approval
  • NICE has recommended durvalumab (Imfinzi) for adults with limited-stage small cell lung cancer whose disease has not progressed after initial treatment, marking the first therapeutic advancement in over 30 years.
  • Clinical trial results showed durvalumab significantly extended median overall survival to 55.9 months compared to 33.4 months with placebo, representing a 22.5-month improvement.
  • The approval addresses a critical unmet need for approximately 530 patients annually in England who previously had no maintenance treatment options after chemoradiotherapy.
  • The immunotherapy drug works by helping the immune system fight cancer and is administered by infusion every 2-4 weeks depending on patient body weight.

ZyVet Launches First FDA-Approved Generic Phenylpropanolamine for Canine Urinary Incontinence

Drug Approval
  • ZyVet Animal Health has released the first FDA-approved generic phenylpropanolamine hydrochloride tablets for treating urinary incontinence in dogs, addressing a condition commonly affecting spayed females and aging dogs.
  • The generic medication provides a cost-effective alternative to branded treatments, with fewer than 20% of FDA-approved animal drugs currently having generic versions available.
  • ZyVet also received FDA approval for generic furosemide tablets for managing congestive heart failure and chronic fluid retention in dogs and cats.
  • The launches reinforce ZyVet's mission to expand affordable veterinary therapeutics, removing cost barriers while maintaining clinical reliability for pet owners and veterinarians.

FDA Approves First Medical Device for Asherman Syndrome, Addressing Major Cause of Female Infertility

Drug Approval
  • The FDA has granted PreMarket Approval to Womed Leaf®, the first medical device approved in the United States specifically for treating moderate to severe intrauterine adhesions associated with Asherman syndrome.
  • The device consists of a soft polymer film that prevents uterine wall contact during healing, addressing a condition that affects 20% to 45% of women undergoing procedures like dilation and curettage.
  • A pivotal clinical study with 160 patients demonstrated that Womed Leaf® significantly reduced adhesion severity compared to no prevention method, offering hope for tens of thousands of women facing infertility.
  • The device will become available in early 2026, marking a significant advancement for women whose fertility is compromised by recurrent intrauterine scarring.

FDA Expands Vyjuvek Label for Home Use and All Ages, Boosting Krystal Biotech's Market Potential

Drug ApprovalRare Disease
  • The FDA approved an updated label for Vyjuvek allowing home administration by families and patients, expanding beyond clinic-only application for dystrophic epidermolysis bullosa treatment.
  • Vyjuvek can now be used in patients from birth, significantly broadening the addressable patient population for Krystal Biotech's gene therapy.
  • The stock surged 14% over the past week and nearly 19% in three months following the regulatory approval, with analysts viewing this as a meaningful turning point for commercial expansion.

FDA Set to Review Five Key Pediatric and Adult Therapies in Q4 2025

Drug ApprovalRare Disease
  • The FDA is scheduled to make approval decisions on five significant therapies in Q4 2025, including treatments for rare pediatric conditions and infectious diseases.
  • Navepegritide represents a potential breakthrough for achondroplasia treatment, designed as a once-weekly prodrug that provides continuous CNP exposure to inhibit the overactive FGFR3 pathway.
  • Two novel oral antibiotics, gepotidacin and zoliflodacin, are under review for gonorrhea treatment in patients 12 years and older, addressing the growing need for new therapeutic options.
  • Roflumilast cream 0.05% could expand atopic dermatitis treatment options for young children aged 2-5 years, based on phase 3 data from 652 pediatric patients.

Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (Integument-PED)

NCT04845620CompletedPhase 3
Arcutis Biotherapeutics, Inc.
Posted 4/7/2021

Novocure's Optune Lua Receives Japanese Approval for Advanced NSCLC Treatment

Drug Approval
  • Japan's Ministry of Health, Labour and Welfare approved Optune Lua for concurrent use with PD-1/PD-L1 inhibitors in adult patients with unresectable advanced/recurrent NSCLC who progressed after platinum-based chemotherapy.
  • The approval was supported by the Phase 3 LUNAR trial, which demonstrated a statistically significant 3.3-month extension in median overall survival (13.2 vs 9.9 months, P=0.04) for patients treated with Optune Lua.
  • The device showed particularly strong results when combined with PD-1/PD-L1 inhibitors alone, extending median overall survival by more than 8 months (19.0 vs 10.8 months, P=0.02).
  • Device-related adverse events occurred in 63.1% of patients but were primarily low-grade skin disorders, with only 4% experiencing Grade 3 toxicity requiring treatment breaks.

A Study of AB-106 in Subjects With Advanced NSCLC Harboring ROS1 Fusion Gene

NCT04395677Active, Not RecruitingPhase 2
AnHeart Therapeutics Inc.
Posted 7/7/2020

Taletrectinib Phase 2 Global Study in ROS1 Positive NSCLC

NCT04919811RecruitingPhase 2
Nuvation Bio Inc.
Posted 9/1/2021

Effect of Tumor Treating Fields (TTFields) (150 kHz) Concurrent With Standard of Care Therapies for Treatment of Stage 4 Non-small Cell Lung Cancer (NSCLC) Following Platinum Failure (LUNAR)

NCT02973789CompletedPhase 3
NovoCure GmbH
Posted 12/1/2016

Seven Real-World Studies Demonstrate NEFECON's Efficacy in IgA Nephropathy Treatment Across Diverse Patient Populations

Real World EvidenceDrug ApprovalTargeted Therapy
  • Seven new real-world evidence studies from leading Chinese hospitals will be presented at the 18th International IgA Nephropathy Symposium, demonstrating NEFECON's efficacy and safety across diverse patient populations including pediatric cases and those with renal insufficiency.
  • The studies validate NEFECON's position as the world's first etiological treatment for IgA nephropathy, showing significant proteinuria reduction and renal function preservation with extended treatment beyond 9 months.
  • NEFECON has achieved regulatory approval from major agencies including FDA, EMA, and NMPA, and was included in China's National Reimbursement Drug List in November 2024, reinforcing its role as first-line cornerstone therapy for IgAN patients.

FDA Moves to Eliminate Expert Advisory Panels for Individual Drug Reviews Under Trump Administration

Drug Approval
  • The FDA under President Trump is abandoning its decades-old policy of convening outside expert panels to review individual drug applications, with officials claiming these meetings are redundant and time-consuming.
  • George Tidmarsh, head of the FDA's Center for Drug Evaluation and Research, stated the agency "would like to get away" from assembling expert panels because "I don't think they're needed" for specific drug evaluations.
  • The FDA has already reduced advisory committee meetings from 22 in the same period last year to only seven since Trump's return, while beginning to publish complete response letters as an alternative transparency measure.
  • Former FDA officials and academics strongly oppose this shift, arguing that expert panels provide crucial independent oversight and public transparency that cannot be replaced by published rejection letters alone.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.