MedPath

Tagged News

FDA Approves First Oral GLP-1 for Weight Management as Q2 2025 Brings Major Endocrinology Advances

Drug Approval
  • Novo Nordisk's 25 mg oral semaglutide for chronic weight management received FDA acceptance in May 2025, potentially becoming the first oral GLP-1 therapy approved for obesity treatment.
  • The FDA cleared Dexcom's G7 15-day CGM system in April 2025, making it the longest-lasting and most accurate CGM approved in the U.S. with 8.0% MARD.
  • Recordati received FDA approval for expanded osilodrostat indication to treat all adults with endogenous Cushing's syndrome who are not surgical candidates.
  • Eton Pharmaceuticals gained FDA approval for the first liquid hydrocortisone formulation for pediatric patients aged 5 and older with adrenocortical insufficiency.

FDA Approves Ritedose's Albuterol Sulfate Inhalation Solution Amid National Shortage

Drug Approval
• Ritedose Pharmaceuticals has received FDA approval for Albuterol Sulfate Inhalation Solution 0.5% (2.5 mg/0.5 mL), completing their portfolio of albuterol treatments amid a nationwide shortage that has persisted since October 2022.
• The newly approved dosage will be manufactured using Blow-Fill-Seal technology in Ritedose's expanded facilities, with availability expected in the second quarter of 2025 to help address critical needs for over 26 million asthma patients.
• This approval strengthens Ritedose's position as the largest provider of nebulizer products in the US, having delivered more than 4.5 billion doses throughout the company's history.

Targeted Therapies Transform Biliary Tract Cancer Treatment as HER2-Directed Agents Gain FDA Approval

Targeted TherapyDrug ApprovalPrecision Medicine
  • The FDA approved two HER2-targeted therapies in 2024 for biliary tract cancer: fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) and zanidatamab-hrii (Ziihera), marking the first targeted therapy approvals for this aggressive cancer.
  • Real-world analysis shows patients with matched targeted therapy achieved median overall survival of 21.4 months compared to 14.6 months for unmatched treatment, demonstrating the clinical value of molecular profiling.
  • Approximately 30% to 40% of biliary tract cancers harbor actionable molecular alterations including FGFR2 fusions, HER2 amplification, KRAS G12C mutations, and IDH1 mutations that can be targeted with approved therapies.
  • Despite these advances, the 5-year overall survival rate for advanced biliary tract cancer remains below 5%, highlighting the continued need for additional effective treatment options.

A Study of ZW25 (Zanidatamab) in Subjects With Advanced or Metastatic HER2-Amplified Biliary Tract Cancers

NCT04466891CompletedPhase 2
Jazz Pharmaceuticals
Posted 10/1/2020

Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations

NCT04579380Active, Not RecruitingPhase 2
Seagen, a wholly owned subsidiary of Pfizer
Posted 1/11/2021

District Court Dismisses United Therapeutics Dispute Against Liquidia in Patent Litigation

Drug Approval
  • A U.S. District Court has dismissed a legal dispute filed by United Therapeutics against Liquidia, marking a significant development in ongoing patent litigation between the two pharmaceutical companies.
  • The dismissal comes amid broader legal proceedings involving Liquidia's YUTREPIA drug candidate, which is currently under FDA review for potential approval.
  • United Therapeutics has filed cross-claims against the FDA as part of the complex litigation landscape surrounding patent disputes in the pharmaceutical sector.
  • The court's decision represents one component of multiple legal proceedings that could impact the competitive dynamics in the pulmonary arterial hypertension treatment market.

Complicated Urinary Tract Infection Pipeline Shows Robust Development with 12+ Companies Advancing Novel Therapies

Drug Approval
  • DelveInsight's 2025 pipeline analysis reveals 12+ pharmaceutical companies actively developing therapies for complicated urinary tract infections, with several candidates in advanced clinical stages.
  • Spero Therapeutics' tebipenem pivoxil hydrobromide completed a landmark Phase III trial (ADAPT-PO) demonstrating non-inferiority to IV ertapenem, potentially becoming the first oral carbapenem approved in the United States.
  • Recent regulatory approvals include GSK's Blujepa (gepotidacin) for uncomplicated UTIs and AbbVie's EMBLAVEO for complicated intra-abdominal infections, highlighting growing treatment options.
  • Multiple Phase III studies are underway in 2025, including pediatric trials by Menarini Group and Rempex evaluating meropenem-vaborbactam combinations for hospitalized patients.

Edwards Lifesciences Receives FDA Approval for TAVR Therapy in Asymptomatic Severe Aortic Stenosis

Drug Approval
  • Edwards Lifesciences received FDA approval for its SAPIEN 3 TAVR therapy to treat asymptomatic severe aortic stenosis patients, marking a significant advancement in cardiac care.
  • New real-world study data from over 24,000 patients demonstrated that early intervention before symptoms develop reduces healthcare costs by $36,000 per patient and decreases hospital stays by 2.2 days.
  • The approval is based on groundbreaking EARLY TAVR trial data showing superior outcomes for asymptomatic patients receiving TAVR compared to clinical surveillance.
  • Early treatment significantly reduces mortality risk, with delayed treatment leading to seven times higher death rates within one year after valve replacement.

CML Treatment Market Poised for Significant Growth Through 2032 Amid Wave of Recent FDA Approvals

OncologyDrug ApprovalFDA Approval
  • The chronic myelogenous leukemia treatment market is expected to experience significant growth through 2032, driven by increasing disease prevalence and multiple recent FDA approvals.
  • Recent regulatory milestones include FDA approvals for Cipla's nilotinib capsules, Marks Shorla's oral liquid imatinib formulation, and Novartis's accelerated approval for Scemblix in newly diagnosed patients.
  • The market features a robust pipeline of emerging therapies from companies including Enliven Therapeutics, Terns Pharmaceuticals, and Ascentage Pharma targeting unmet needs in resistant cases.
  • Current epidemiological data shows approximately 9,280 new CML diagnoses expected in the US in 2024, with 85-90% of patients diagnosed during the chronic phase.

Alembic Pharma Shares Surge Following USFDA Clearance of Panelav Oncology Facility

Drug ApprovalOncology
  • Alembic Pharmaceuticals received an Establishment Inspection Report (EIR) from the USFDA for its Panelav oncology formulation facility following a clean inspection conducted from October 7-8, 2024.
  • The company's shares surged 4.21% to ₹1,246.65 on the NSE following the announcement, adding approximately ₹1,000 crore to its market capitalization.
  • The clean EIR with no Form 483 observations reinforces Alembic's regulatory compliance and strengthens its position in the US generics and oncology markets.
  • This marks the second successful USFDA inspection at Panelav facilities in 2024, following a clean EIR for the F-1 facility in September 2024.

Achieve Life Sciences Files for FDA Approval of Cytisinicline, First New Smoking Cessation Drug in Nearly 20 Years

Drug Approval
  • Achieve Life Sciences has filed for FDA approval of cytisinicline, which would be the first new smoking cessation medication in nearly 20 years if approved.
  • Phase 3 trials demonstrated a 20.5% effectiveness rate for cytisinicline compared to 5% for placebo, with fewer side effects than existing treatments like varenicline.
  • FDA approval is expected by mid-2026 with U.S. market launch by the end of that year, targeting the 29 million Americans who currently smoke cigarettes.
  • The drug addresses a significant unmet need as less than 1% of smokers succeed in quitting annually despite 67.7% expressing desire to quit.

FDA Approves J&J's Akeega for BRCA-Positive Metastatic Prostate Cancer

Drug ApprovalPrecision MedicineOncology
  • Johnson & Johnson received FDA approval for Akeega, a combination tablet containing niraparib and abiraterone acetate, for first-line treatment of adults with BRCA-positive metastatic castration-resistant prostate cancer.
  • The approval is based on the MAGNITUDE phase 3 trial, which demonstrated a 47% improvement in radiographic progression-free survival compared to standard of care in BRCA1/2 mutation patients.
  • The FDA approval restricts Akeega's use to patients with BRCA1 or BRCA2 mutations, affecting 10-15% of mCRPC patients who typically experience poorer outcomes and shorter survival times.
  • Akeega competes with AstraZeneca and MSD's Lynparza combination and Pfizer's Talzenna, all targeting the same BRCA-mutated patient population in the US market.

MedPath

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

© 2025 MedPath, Inc. All rights reserved.