Brand & Product Security

Articles

Aglatimagene besadenovec and prodrug plus chemoradiation prior to surgery was found to produce an extended and sustained survival benefit among patients with borderline resectable pancreatic ductal adenocarcinoma. 

Novel Therapy for Pancreatic Ductal Adenocarcinoma Fast Tracked by FDA

Popular works in the category explore 340B guidelines, ‘smart pharma’ capabilities, and commercialization trends.

Filsuvez Topical Gel Approved by FDA for Wounds Associated With Epidermolysis Bullosa 

FDA expands indication for LEO Pharma’s Adbry (tralokinumab-ldrm) to include patients 12 to 17 years of age with moderate-to-severe atopic dermatitis.

FDA Approves Expanded Indication for Adbry in Atopic Dermatitis 

Arcutis Biotherapeutics said Zoryve foam will be widely available via key wholesaler and dermatology pharmacy channels by the end of January 2024.

FDA Approves Zoryve Topical Foam for Seborrheic Dermatitis

The FDA previously granted the application for Padcev (enfortumab vedotin-ejfv) plus Keytruda (pembrolizumab) with priority review and breakthrough designation for patients with locally advanced or metastatic urothelial cancer.

FDA Approves Padcev Plus Keytruda for Urothelial Cancer 

The FDA based the approval Merck’s Welireg (belzutifan) on findings from the randomized, open-label, Phase III LITESPARK-005 trial, which compared Welireg to Afinitor for the treatment of advanced RCC that has progressed after prior treatment with PD-1/L1 and VEGF-TKI therapies.

FDA Approves HIF-2α Inhibitor for Patients With Advanced Renal Cell Carcinoma

Eflornithine (Iwilfin) is indicated to lower the risk of relapse in adult and pediatric patients with high-risk neuroblastoma who showed at least a partial response to previous multi-agent and multimodality treatment that included an anti-GD2 immunotherapy.

FDA Approves Treatment to Lower Relapse in High-Risk Neuroblastoma 

The seminar examines where members of the pharma supply chain stand in terms of preparation, being that the act has officially been enacted. 

Trade & Channel Strategies 2023: A DSCSA Update

FDA approves bluebird bio’s Lyfgenia and Vertex Pharmaceuticals' and CRISPR Therapeutics’ Casgevy for the treatment of sickle cell disease, which affects approximately 100,000 people in the United States.

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