Ilaris for Gout, Generics for ADHD, Balversa for Urothelial Cancer, INO-3107 for Recurrent Respiratory Papillomatosis, Crovalimab for PNH

New FDA Approvals

In this week's New FDA Approval's podcast episode, Dr. Emma Hitt Nichols discusses the latest FDA approvals from August 28, 2023 – September 8, 2023. Please check back every Monday morning so that you can stay up to date.

Here is information on the latest US FDA approvals, the week of August 28 – September 8, 2023.

Check out our free downloads at nascentmc.com:

• Implementing AMA Style – 8 Things to Get Right in Your Next Project
• Needs Assessments – 7 Essentials for Getting Funded
• Working With Your Medical Writer – 8 Ways to Get the Most out of Them

See the full write ups for today's episode at nascentmc.com/podcast

Here are the highlights:

• Ilaris for Gout Flares in Adults: FDA approved Ilaris (canakinumab) for adult gout flares when other treatments failed; previously approved for CAPS and other diseases.
• Generics of ADHD Medication: FDA approved several generic versions of Vyvanse; Takeda's patent expired; medication was in short supply due to manufacturing issues.
• sNDA for Balversa in mUC: Janssen submitted sNDA for Balversa for urothelial carcinoma patients with specific genetic alterations; previously granted accelerated approval in 2019.
• INO-3107 for RRP: FDA granted Breakthrough Therapy designation for INO-3107 for recurrent respiratory papillomatosis caused mainly by HPV-6/11; Inovio to initiate a trial in 2024.
• Crovalimab for PNH: FDA accepted BLA for crovalimab as a treatment for PNH based on positive Phase III study results; potential approval expected late 2023/early 2024.
• Intro and outro music

Garden Of Love by Pk jazz Collective