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Taiwan Accepts Everest Medicines' VELSIPITY Application for Ulcerative Colitis Treatment

Drug Approval
  • Taiwan's Food and Drug Administration has officially accepted Everest Medicines' New Drug Application for VELSIPITY (etrasimod) to treat moderately to severely active ulcerative colitis.
  • The acceptance builds on prior approvals in Singapore, Hong Kong SAR, and Macao SAR, marking significant progress in VELSIPITY's commercialization across Asia.
  • Clinical data supporting the application comes from Phase 3 studies including the ENLIGHT trial, which enrolled 340 Asian patients and achieved mucosal healing in 51.9% of treated patients.
  • With approximately 800,000 UC patients in China in 2024 projected to reach 1 million by 2030, the drug addresses a significant unmet medical need in the region.

Liquidia's YUTREPIA Achieves Rapid Market Uptake with 900+ Prescriptions in 11 Weeks Post-Approval

Drug ApprovalRare Disease
  • Liquidia Corporation's YUTREPIA (treprostinil) inhalation powder achieved over 900 unique patient prescriptions and 550 patient starts within 11 weeks of FDA approval for treating PAH and PH-ILD.
  • The ASCENT trial interim data demonstrated sustained efficacy with median improvements in six-minute walk distance of 31.5 meters at Week 16, with no discontinuations due to drug-related adverse events.
  • The company reported $6.5 million in product revenue for Q2 2025 and maintains a strong financial position with $173.4 million in cash and cash equivalents.

PolyPid Appoints Dr. Nurit Tweezer-Zaks as Chief Medical Officer Following Positive Phase 3 Results

Drug Approval
  • PolyPid Ltd. has appointed Dr. Nurit Tweezer-Zaks as Chief Medical Officer, effective August 18, 2025, following positive Phase 3 SHIELD II trial results for their lead product candidate D-PLEX100.
  • Dr. Tweezer-Zaks transitions from the company's Board of Directors to lead medical strategy as PolyPid prepares for New Drug Application submission expected in early 2026.
  • The appointment comes at a pivotal time as the company advances its pipeline including D-PLEX100 for preventing abdominal colorectal surgical site infections and a recently unveiled GLP-1 program.

Viatris Secures FDA Approval for First Generic Iron Sucrose Injection with 180-Day Market Exclusivity

Drug Approval
  • Viatris received FDA approval for the first generic version of iron sucrose injection, used to treat iron deficiency anemia in chronic kidney disease patients aged 2 years and older.
  • The approval includes competitive generic therapy designation for two strengths, granting 180 days of market exclusivity and expedited regulatory review.
  • Iron deficiency anemia is a common complication of chronic kidney disease associated with significantly heightened cardiovascular morbidity and higher mortality rates.
  • The generic product targets a market where the brand-name Venofer had annual U.S. sales of approximately $515 million as of June 2025.

Zydus Lifesciences Secures FDA Approval for Generic Diltiazem Tablets to Treat Angina and Hypertension

Drug Approval
  • Zydus Lifesciences received final FDA approval for Diltiazem Hydrochloride tablets in four strengths (30 mg, 60 mg, 90 mg, and 120 mg) for treating chronic stable angina and coronary artery spasm.
  • The calcium-channel blocker works by relaxing blood vessels to reduce cardiac workload and improve blood and oxygen supply to heart muscle.
  • The approved generic formulation targets a US market worth $13.9 million annually according to IQVIA data, with production planned at the company's Baddi facility in India.

Amphastar Receives FDA Approval for Generic Iron Sucrose Injection to Treat Anemia in Chronic Kidney Disease Patients

Drug Approval
  • Amphastar Pharmaceuticals received FDA approval for its generic iron sucrose injection (AMP-002) in three dosage strengths for treating iron deficiency anemia in chronic kidney disease patients.
  • The FDA determined that Amphastar's iron sucrose injection meets bioequivalence and therapeutic equivalence criteria to the reference drug Venofer®, which generated approximately $513 million in U.S. sales over the past 12 months.
  • The company plans to launch the generic iron sucrose injection in the third quarter of 2025, adding to its pipeline of complex generic and biosimilar products targeting markets worth over $9.5 billion combined.

Kamada Receives FDA Approval for Houston Plasma Collection Center, Expanding Specialty Plasma Operations

Drug Approval
  • Kamada Ltd. received FDA approval for its Houston plasma collection center following a second quarter 2025 inspection, clearing the facility to commence commercial sales of normal source plasma.
  • The 12,000 square foot facility features 50 donor beds with an annual collection capacity of approximately 50,000 liters and projected revenue contribution of $8-10 million at full capacity.
  • The Houston center is anticipated to become one of the largest specialty plasma collection sites in the U.S., collecting both normal source plasma and specialty plasma including anti-rabies and anti-D products.
  • Combined with existing facilities in Beaumont and San Antonio, Texas, Kamada now operates three plasma collection centers to support its portfolio of FDA-approved plasma-derived therapies for rare conditions.

Shilpa Medicare Receives World's First Approval for NorUDCA, Novel NAFLD Treatment

Drug Approval
  • Shilpa Medicare has received historic approval for NorUDCA, marking the first-in-class treatment for non-alcoholic fatty liver disease (NAFLD) in India and making it the first company globally to obtain approval for this indication.
  • NAFLD affects approximately 25% of the world's population (1.2 billion people) and impacts an estimated 188 million individuals in India alone, representing the most prevalent liver condition globally.
  • Clinical results demonstrate NorUDCA's superior efficacy compared to placebo, showing significant improvement in both liver structure and function for NAFLD patients.
  • The company plans to launch NorUDCA tablets in India immediately while advancing global regulatory efforts to bring this vital therapy to patients internationally.

FDA Approves Boehringer Ingelheim's HERNEXEOS as First-in-Class HER2 TKI for Rare Lung Cancer Subset

Drug ApprovalPrecision Medicine
  • The FDA granted accelerated approval to HERNEXEOS (zongertinib) in August 2025, marking the first oral therapy specifically targeting HER2 tyrosine kinase domain mutations in non-squamous NSCLC.
  • Clinical data demonstrated a 75% objective response rate in previously untreated patients and 96% disease control rate, with a more manageable safety profile compared to existing treatments.
  • The approval addresses an aggressive cancer subset affecting 2-4% of lung cancer patients and represents a significant advancement in precision oncology for underserved populations.

FDA Approves First Liquid Embolic System for Hypervascular Tumor Treatment

Drug Approval
  • The FDA has granted premarket approval to the Embrace Hydrogel Embolic System, marking the first liquid embolic specifically approved for hypervascular tumor embolization based on randomized controlled trial data.
  • The PEG hydrogel system demonstrated 88.6% technical success and 99% freedom from major adverse events at 30 days in a pivotal study of 150 patients across 22 institutions.
  • The system addresses critical limitations of traditional embolic agents by enabling deep penetration into vessels as small as 10 microns while avoiding catheter entrapment and imaging artifacts.
  • Hypervascular tumors in the liver, kidney, and bone present significant surgical challenges due to bleeding risk, making this new embolization option particularly valuable for non-surgical candidates.

Instylla HES Hypervascular Tumor Pivotal Study

NCT04523350CompletedNot Applicable
Instylla, Inc.
Posted 1/4/2021

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