FDA Gives Nod to RSV Vaccine for People in Their 50s

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Medically reviewed by Drugs.com.
By Ernie Mundell HealthDay Reporter

The U.S. Food and Drug Administration on Friday has for the first time approved the use of a respiratory syncytial virus (RSV) vaccine for people in their 50s who are at increased risk for the illness.

  • Drugmaker GSK’s Arexvy vaccine, as well as vaccines from Pfizer and Moderna, are already
    approved for use in adults 60 and older, since age brings higher risk from RSV disease.
  • Arexvy is the first to get the nod for people ages 50 to 59 with certain health risk factors.

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FDA Approves mRESVIA for Prevention of Lower Respiratory Tract Disease Causedby RSV

by News

The FDA has approved mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection.

  • The approval was granted under a breakthrough therapy designation and marks the second
    approved mRNA product from Moderna. The vaccine uses the same lipid nanoparticles (LNPs) as
    the Moderna COVID-19 vaccines.
  • Moderna expects to have mRESVIA available for eligible populations in the U.S. by the 2024/2025
    respiratory virus season.
    Source: Moderna, Inc.

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MYHIBBIN™

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FDA Approves Myhibbin Oral Suspension for Prophylaxis of Organ Rejection

Azurity Pharmaceuticals, has announced that the FDA has approved Myhibbin, the only ready-to-use mycophenolate mofetil oral suspension. Mycophenolate mofetil is an antimetabolite immunosuppressant used to protect a donated organ from being rejected from the body’s immune response.

  • In 2023, there were over 46,000 transplants in the U.S. and these patients need to take medication every day to fight against rejection.
  • Myhibbin is indicated for the prophylaxis of organ rejection in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart, or liver transplants, in combination with other immunosuppressants.
  • It is expected that Myhibbin will become commercially available in pharmacies nationwide in Q2 2024.

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