News

FDA clears Ensoma’s application for rare genetic disorder treatment
A Phase I/II trial is set to assess the therapy’s potential efficacy and safety, as well as determine an appropriate dose.
Health Affairs21h
In Price Negotiations, Medicare Should Reassess How It Determines A ‘Qualifying Single Source Drug’
Conflicting QSSD definitions from two federal agencies mean that CMS’ administrative authority on drug pricing and payment is ...
Multiple Sclerosis News Today1h
Quantum Biopharma to seek FDA OK for Phase 2 trial of Lucid-MS
Quantum Biopharma plans to file an application by year's end seeking FDA clearance for a Phase 2 clinical trial testing Lucid ...
Targeted Oncology2d
The Targeted Pulse: New Therapies for Melanoma, Myeloma, and More
The FDA has cleared investigational new drug applications and handed out fast track designations. Plus, data shows promise for novel therapies in hard-to-treat cancers.
Novo Nordisk Says FDA Accepted New Drug Application for Wegovy Pill
The Bagsvaerd, Denmark, company said that if the application is approved, Wegovy would become the first oral formulation of a ...
Managed Healthcare Executive6d
FDA Sets Goal Date for Antipsychotic Drug, Bysanti
The FDA has accepted the new drug application for the antipsychotic Bysanti and set a goal date for February 21, 2026.
Targeted Oncology3d
FDA Clears IND for Novel DLL3-Targeted ADC in Solid Tumors
The FDA cleared the investigational new drug application of IDE849, a potential first-in-class DLL3-targeted antibody-drug ...
The Cardiology Advisor6d
FDA Decision on Barth Syndrome Therapy Delayed Again
The FDA has communicated to Stealth BioTherapeutics that it would not meet elamipretide’s PDUFA target date for the treatment of Barth syndrome.
MPR5d
Birth Control Patch With Lower Estrogen Dose Effective in Phase 3 Trial
The investigational transdermal delivery system, known as Xulane Lo, is designed to deliver 150mcg of norelgestromin and 17.5mcg of ethinyl estradiol per day.