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Fruquintinib (Fruzaqla) is the first novel chemotherapy-free treatment option approved for metastatic colorectal cancer in more than a decade.

FDA Approves New Chemotherapy-Free Treatment Option for Metastatic Colorectal Cancer 

Tirzepatide (Zepbound; Eli Lilly and Company) is expected to be available in the United States by the end of 2023 with a list price of $1,059.87.

FDA Approves Zepbound for Chronic Weight Management

Company aims to receive approval on a Type II Variation application for Sirturo for patients with pulmonary tuberculosis. 

Janssen Sends Data for Phase III Children’s Pulmonary Tuberculosis Treatment to FDA and EMA

The online promotion of intravenous infusions and oral forms of subanesthetic ketamine for the treatment of mental health conditions has been found to frequently carry misleading or false information.

Concerns Raised Over False Claims in Direct-to-Consumer Online Marketing of Ketamine 

Exagamglogene autotemcel (Exa-Cel) was assigned a Prescription Drug User Fee Act action date of December 8, 2023, for the treatment of sickle cell disease.

Vertex Pharmaceuticals Touts Potential of CRISPR Gene Editing Therapy

Surge acted as a precursor for the RSV-marketed drug landscape in 2023, says GlobalData.

RSV Designations Reached All-Time High in 2022, Data Shows 

Meg Rivers is the former managing editor of 

Amy West, Head of US Digital Health & Innovation Strategy at Novo Nordisk, shares her insights on fostering collaboration, embracing change, and her compelling vision to revolutionize digital transformation and innovation in the field of healthcare.

Q&A with Amy West, Head of US Digital Health & Innovation Strategy at Novo Nordisk

Multiple regulatory pathways exist during the drug development process.

Combining Regulatory Pathways to Optimize Development Efficiency

Mike Hollan is an assistant managing editor for 

 and can be reached at mhollan@mjhlifesciences.com.

Klein discusses how recent FDA draft guidelines will impact the use of SaMD in the life sciences industry.

Regulating SaMD: Q&A With David Klein, Co-Founder and CEO of Click Therapeutics

The proposed rule is aimed at ensuring the safety and effectiveness of the tests.