Articles

Data from the EMERGENT clinical trial program show Karuna Therapeutics, Inc’s KarXT (xanomeline-trospium) produced statistically significant and clinically meaningful improvements in the symptoms of schizophrenia.

FDA Accepts New Drug Application for Novel Schizophrenia Treatment

The clearance includes the Vivos Therapeutics, Inc's DNA oral appliance, the mRNA oral appliance, and the mmRNA oral appliance for adults with severe obstructive sleep apnea.

FDA Grants 510(k) Clearance to Obstructive Sleep Apnea Oral Appliance

Patient-first trial design, based around the tenets of adaptability and personalization, has emerged as a key solution to increase diversity and improve trial outcomes for all.

Increasing Clinical Trial Diversity Through Patient-First Payment Options

Results from decade-long analysis suggest great improvement is needed in the quality of control groups.

Study Examines Use of Optimal Control Groups in Randomized Clinical Trials for Systemic Rheumatic Diseases

The Elecsys HBeAg quant can detect the presence and quantity of the hepatitis B e antigen (HBeAg) in human serum and plasma.

Roche Launches Immunoassay to Detect Acute Hepatitis B Infection

Results from the Phase 3 DeFi trial (NCT03785964) showed that nirogacestat (Ogsiveo) reduced the risk of disease progression or mortality by 71% compared with placebo.

FDA Approves First Treatment for Adults With Progressing Desmoid Tumors 

Epcoritamab-bysp (Epkinly; AbbVie and Genmab) is a T-cell engaging bispecific antibody under evaluation for the treatment of adults with follicular lymphoma that is relapsed or refractory following treatment with two or more therapies.

FDA Awards Breakthrough Designation to Epkinly for Follicular Lymphoma 

The FDA granted Fast Track Designation to ADP101 based on findings from the phase 1/2 Harmony trial (NCT04856865), which analyzed the safety and efficacy of the novel treatment in desensitizing patients with single or multiple food allergies. 

FDA Grants Fast Track Designation to Investigational Food Allergy Immunotherapy 

Increased use of laboratory-developed tests emphasizes inaccuracy and need for regulatory intervention.

Additional Oversight Needed Amidst Increased Use of Laboratory-Developed Tests

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

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