Mirvetuximab Soravtansine Granted Priority Review for Ovarian Cancer
Mirvetuximab soravtansine is an antibody-drug conjugate comprised of a FRα-binding antibody, a cleavable linker, and a potent tubulin-targeting agent.
All articles by Tony Morbin
Mental Health Services Underutilized in Pediatric IBD Patients
Inflammatory bowel disease (IBD) diagnosis appears to be associated with high levels of anxiety and depression in children, however, new study findings presented at the 2019 AIBD Annual Meeting suggest that many of these patients may not be receiving appropriate mental health services.
FDA to Review Omalizumab for Chronic Rhinosinusitis With Nasal Polyps
The Food and Drug Administration (FDA) has accepted for filing the supplemental Biologics License Application (sBLA) for omalizumab (Genentech) for the treatment of adults with chronic rhinosinusitis with nasal polyps who have had an inadequate response to intranasal corticosteroids. The sBLA includes data from the POLYP 1 and POLYP 2 trials, which showed that treatment…
Eylea in Single-Dose Prefilled Syringe Now Available
The prefilled syringe requires fewer preparation steps than the vial.
Intranasal Therapy Fast-Tracked for Social Anxiety Disorder
The FDA has granted Fast Track designation to PH94B (aloradine; VistaGen Therapeutics), a central nervous system neuroactive nasal spray for the on-demand treatment of social anxiety disorder.
AGS: Beers Criteria for Potentially Inappropriate Med Use in Older Adults Updated
Over 1400 clinical trials and research studies were reviewed by a panel of 13 experts to develop the new guideline.
Does DPP-4 Inhibitor Use Increase the Risk of Developing IBD?
To investigate the association between this diabetes drug class and IBD risk, the study authors searched various databases for controlled clinical trials and observational studies involving DPP-4 inhibitors where IBD events were reported.
Investigational Treatment for Multiple System Atrophy Gets Orphan Drug Status
Currently, there are no approved therapies for the treatment of MSA, a rare progressive neurodegenerative disease.
New Treatment Option for Serious Fungal Infections Now Available
Tolsura, which contains the azole antifungal itraconazole, is formulated using the Company’s proprietary SUBA (SUper-BioAvailable) technology which improves the bioavailability of poorly soluble drugs.
FDA Grants Breakthrough Therapy to 15-Valent Pneumococcal Conjugate Vaccine
Phase 3 studies investigating safety, tolerability, and immunogenicity in both adults and children are currently underway.
