Articles related to DEVICE/DRUG APPROVALS

Amtagvi’s approval introduces a novel approach in the treatment of advanced melanoma, employing patient-derived TIL-cell therapy to target tumors with precision, offering a beacon of hope for those with limited options.

The FDA’s approval of irinotecan liposome with oxaliplatin, fluorouracil, and leucovorin marks a pivotal advancement in first-line treatment options for metastatic pancreatic adenocarcinoma, showcasing a notable increase in overall and progression-free survival rates.

In the fast-evolving landscape of oncology treatment, a new study reveals oncologists’ unique stance on FDA approval processes, emphasizing the importance of timely access to potentially life-saving drugs despite conventional evidentiary standards.

The FDA’s recent update to Paxlovid’s EUA ensures a seamless transition to NDA-labeled nirmatrelvir+ritonavir for treating high-risk pediatric patients, reflecting a commitment to adaptability and patient care in the ongoing fight against COVID-19.

Zurzuvae represents a novel approach in postpartum depression therapy, with clinical trials revealing substantial symptom reduction within the initial treatment period. This advancement offers a new horizon in PPD management for healthcare professionals.

HyQvia, now FDA-approved for CIDP, shows a significant reduction in relapse rates, presenting an effective subcutaneous alternative to IVIG infusions.