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Articles

Supplemental new drug application for roflumilast cream 0.15% to treat atopic dermatitis in patients 6 years of age and older was assigned a Prescription Drug User Fee Act target action date of July 07, 2024.

FDA Accepts Arcutis Biotherapeutics' sNDA for Roflumilast Cream for Atopic Dermatitis

KarXT (xanomeline-trospium) is currently in development to treat schizophrenia and psychosis related to Alzheimer disease. 

FDA Accepts New Drug Application for Karuna Therapeutics' Novel Schizophrenia Drug

Vivos becomes the first company to bring to market an alternative to continuous positive airway pressure (CPAP) or surgical neurostimulation implants for patients with severe OSA.

Vivos Therapeutics' Obstructive Sleep Apnea Oral Appliance Gains FDA 510(k) Clearance 

The launch of the Elecsys HBeAg quant immunoassay adds to Roche's viral hepatitis testing portfolio.

Roche Announces Launch of New Tool to Improve Hepatitis B Detection

Ogsiveo is the first and only drug approved by the FDA to treat desmoid tumors.

FDA Approves Ogsiveo to Treat Desmoid Tumors

Trial results expected to accelerate the potential of Dupixent to become the first FDA-approved treatment for chronic obstructive pulmonary disease. 

Phase 3 Clinical Trial for Dupixent Reports Significant Reduced COPD Exacerbations

AbbVie and Genmab will share commercial responsibilities in the United States and Japan for epcoritamab-bysp (Epkinly), whereas AbbVie will be responsible for further global commercialization.

Follicular Lymphoma Drug Co-Developed by AbbVie and Genmab Gets FDA Breakthrough Designation

Manufacturer states that novel drug is the most advanced multi-food oral immunotherapy drug candidate currently in development.

Alladapt Immunotherapeutics' Oral Immunotherapy for Multiple Food Allergies Gets FDA Fast Track Designation

Study aims to find ways industry gets involved in the most influential clinical trials, and how transparent these trials are.

 Investigating Industry Involvement in Modern Clinical Trials

Enzalutamide (Xtandi) from Astellas Pharma Inc. and Pfizer Inc. gets FDA approval to treat nonmetastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis.

R&D/Clinical Trials