Upcoming FDA event : IOVA, ALVO, NERV, EYEN, VNDA, MIRM, JNJ, MDGL

 The provided information outlines upcoming events and FDA decisions related to various pharmaceutical companies and their respective drugs. Here's a summary:

1. Ipsen SA (IPSEY):

   • Drug: Onivyde (sNDA)
   • Event Date: 02/13/2024
   • FDA Decision: Pending
   • Purpose: Decision on Onivyde plus NALIRIFOX regimen for expanded use in first-line treatment for metastatic pancreatic ductal adenocarcinoma.

2. Iovance Biotherapeutics, Inc. (IOVA):

   • Drug: Lifileucel (BLA)
   • Event Date: 02/24/2024
   • FDA Decision: Pending
   • Purpose: Decision on Lifileucel for patients with advanced melanoma.

3. Alvotech (ALVO):

   • Drug: AVT02 (Resubmitted BLA)
   • Event Date: 02/24/2024
   • FDA Decision: Pending
   • Purpose: Decision on AVT02, an interchangeable biosimilar candidate to Humira.

4. Minerva Neurosciences Inc (NERV):

   • Drug: Roluperidone (NDA)
   • Event Date: 02/26/2024
   • FDA Decision: Pending
   • Purpose: Decision on Roluperidone for the treatment of negative symptoms in schizophrenia.

5. EYENOVIA, INC. (EYEN):

   • Drug: APP13007 (NDA)
   • Event Date: 03/04/2024
   • FDA Decision: Pending
   • Purpose: Decision on APP13007 for the treatment of inflammation and pain following ocular surgery.

6. VANDA PHARMACEUTICALS (VNDA):

   • Drug: HETLIOZ (sNDA)
   • Event Date: 03/04/2024
   • FDA Decision: Pending
   • Purpose: Decision on the expanded use of HETLIOZ in the treatment of insomnia characterized by difficulties with sleep initiation.

7. Viatris Inc. (VTRS):

   • Drug: GA Depot 40 mg (NDA)
   • Event Date: 03/08/2024
   • FDA Decision: Pending
   • Purpose: Decision on GA Depot for Relapsing Forms of Multiple Sclerosis.

8. Mirum Pharmaceuticals Inc. (MIRM):

   • Drug: LIVMARLI (sNDA)
   • Event Date: 03/13/2024
   • FDA Decision: Pending
   • Purpose: Decision on the expanded use of LIVMARLI in progressive familial intrahepatic cholestasis.

9. Johnson & Johnson (JNJ):

   • Drug: CARVYKTI (sBLA)
   • Event Date: 03/14/2024
   • FDA Panel Review: Pending
   • Purpose: FDA panel to review CARVYKTI for expanded use in treating adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy.

10. MADRIGAL PHARMACEUTICALS, INC. (MDGL):

• Drug: Resmetirom (NDA)
• Event Date: 03/14/2024
• FDA Decision: Pending
• Purpose: Decision on Resmetirom for the treatment of adult patients with NASH with liver fibrosis.

Please note that the information provided is based on the events and decisions mentioned, and you may want to follow up with official sources or financial experts for the latest updates and analysis.