Lynparza Demonstrates Prolonged Survival Benefit in Early Breast Cancer with BRCA Mutation
Lynparza (olaparib) shows sustained improvement in overall survival for patients with germline BRCA-mutated, HER2-negative, high-risk early breast cancer.
Bionxt Solutions to Evaluate Sublingual Cladribine Formulation for Multiple Sclerosis in Clinical Trial
Bionxt Solutions plans to initiate a clinical trial in the second half of 2025 to assess its sublingual cladribine formulation, BNT23001, for treating multiple sclerosis.
Cardiff Oncology's Onvansertib Shows Promising Results in RAS-Mutated Metastatic Colorectal Cancer Trial
Cardiff Oncology's onvansertib, combined with standard-of-care, demonstrated a 64% objective response rate (ORR) in first-line RAS-mutated metastatic colorectal cancer (mCRC) patients.
Givlaari Demonstrates Effectiveness in AIP Patients Often Excluded from Clinical Trials
A real-world study in Germany found that Givlaari effectively prevents severe acute attacks and reduces chronic health burden in acute intermittent porphyria (AIP) patients.
Aptevo's Mipletamig Achieves 100% Remission Rate in Frontline AML Trial
Aptevo Therapeutics' mipletamig, combined with venetoclax and azacitidine, achieved a 100% remission rate within 30 days in Cohort 1 of the RAINIER trial for frontline AML.
iTeos Therapeutics' Inupadenant Shows Promise in NSCLC Phase 2 Trial
iTeos Therapeutics reported a 63.9% overall response rate (ORR) in a Phase 2 trial of inupadenant plus chemotherapy for metastatic non-small cell lung cancer (NSCLC).
Mosunetuzumab Shows Promise in Follicular Lymphoma, Ongoing Trials Explore Efficacy
Mosunetuzumab demonstrates a high objective response rate of 95% and a complete metabolic response rate of 83.3% in previously untreated, low-tumor burden follicular lymphoma patients.
Ocugen's OCU400 Shows Promise in Retinitis Pigmentosa Treatment with Positive Clinical Data and Regulatory Milestones
Ocugen's OCU400 gene therapy demonstrated a statistically significant improvement in low-luminance visual acuity in patients with retinitis pigmentosa (RP).
Luspatercept Demonstrates Sustained Transfusion Independence in Myelodysplastic Syndromes
The COMMANDS trial reveals luspatercept's superior long-term efficacy over epoetin alfa in achieving transfusion independence in patients with myelodysplastic syndromes (MDS).
Yuhan's Lung Cancer Drug Leclaza Secures European Approval in Combination Therapy
Yuhan Corporation's third-generation EGFR-TKI lazertinib (Leclaza) has received European Commission approval in combination with J&J's Rybrevant for first-line treatment of EGFR-mutated non-small cell lung cancer.
Xgene's XG005 Demonstrates Significant Pain Reduction in Phase 2 Bunionectomy Trial
Xgene Pharmaceutical's XG005 showed a statistically significant reduction in post-surgical pain compared to placebo in patients undergoing bunionectomy.
Allo-SCT Demonstrates Long-Term Superiority Over Standard Care in Sickle Cell Anemia
Allogeneic stem cell transplantation (allo-SCT) shows significant improvements in sickle cell anemia (SCA) patients compared to standard of care (SOC) over 10 years.
Belzutifan Plus Cabozantinib Shows Promise as First-Line Treatment for Advanced Clear Cell Renal Cell Carcinoma
The combination of belzutifan and cabozantinib demonstrates promising antitumor activity in treatment-naive patients with clear cell renal cell carcinoma (ccRCC).
Long-Term Biologic Therapy Shows Sustained Efficacy in Chronic Rhinosinusitis with Nasal Polyps
A 4-year study confirms the sustained efficacy and tolerability of biologics like Dupilumab, Mepolizumab, and Omalizumab for treating chronic rhinosinusitis with nasal polyps (CRSwNP).
FDA Grants Fast Track Designation to Lipocine's LPCN 1148 for Sarcopenia in Decompensated Cirrhosis
The FDA has granted Fast Track designation to Lipocine's LPCN 1148 for treating sarcopenia in patients with decompensated cirrhosis, addressing an unmet medical need.
Omacetaxine Plus Azacitidine Shows Favorable Safety and Long-Term Outcomes in Advanced MDS
Combination therapy with omacetaxine and azacitidine demonstrates a manageable safety profile in patients with myelodysplastic syndromes (MDS) with excess blasts.
Tempus Presents New Breast Cancer Research at SABCS 2024, Highlighting AI-Driven Precision Medicine
Tempus presented research at SABCS 2024, showcasing the use of real-world data and AI to improve outcomes for breast cancer patients.
ATAI Life Sciences Reports Positive Q3 2023 Financials and Advances Clinical Pipeline
ATAI Life Sciences reported a net income of $44.2 million for Q3 2023, a significant increase compared to the previous year, driven by non-cash gains.
Swissmedic Grants Temporary Authorization to Lytgobi for FGFR2-Rearranged Cholangiocarcinoma
Swissmedic has granted temporary authorization to Lytgobi (futibatinib) for treating locally advanced or metastatic cholangiocarcinoma with FGFR2 rearrangement.
Akebia Resubmits FDA Application for Vadadustat in Dialysis-Dependent CKD Anemia
Akebia Therapeutics has resubmitted its New Drug Application (NDA) to the FDA for vadadustat for anemia due to chronic kidney disease in adults on dialysis.