Ruxolitinib Cream Gets Priority Review for Vitiligo Treatment
The application is supported by data from the phase 3 TRuE-V clinical trial program.
Diagnosis & Disease Information
Companies Selling Unapproved Drugs for Mole, Skin Tag Removal Get FDA Warning Letter
The Companies are in violation of the FD&C Act, as these products are being marketed with unauthorized claims to remove lesions, including moles and skin tags.
Vilobelimab Fast Tracked for Ulcerative Pyoderma Gangrenosum
Vilobelimab is a first-in-class anti-human complement factor C5a monoclonal antibody.
Dupilumab Gets Priority Review for Prurigo Nodularis
The sBLA is supported by data from the phase 3 PRIME2 and PRIME trials that assessed dupilumab in patients 18 years of age and older with prurigo nodularis.
FDA Adds Restrictions, Updates Labeling for Breast Implants
The FDA has approved new labeling requirements for all legally marketed breast implants that include a Boxed Warning, patient decision checklist, and other safety measures.
FDA Clears Neurostimulation Device to Prevent Pressure Injuries
According to studies, Prelivia was found to increase tissue oxygenation by 28% and decrease pressure induced tissue damage by 80%.
FDA Issues Complete Response Letter for Burn Therapy NexoBrid
NexoBrid is a topically administered, bromelain-based biological product containing a sterile mixture of proteolytic enzymes.
RECELL System Approval Expanded to Pediatric Patients, Extensive Burn Wounds
The pediatric approval was based on data from the RECELL Compassionate Use (IDE 15945) and Continued Access (IDE 13053) studies.
Repigmentation Observed With Ruxolitinib Cream in Vitiligo Trials
Results from both studies demonstrated that ruxolitinib met the primary endpoint with a greater proportion of patients achieving F-VASI75 at week 24.
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