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

by Uncategorized

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™

by NewsUncategorized

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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ZITUVIO

by BusinessNews

FDA Approves Zituvio (sitagliptin) for the Treatment of Adult Patients with Type 2 Diabetes Mellitus
Zydus Lifesciences has announced that the U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for Zituvio (Sitagliptin) tablets, 25 mg, 50 mg, and 100 mg. Zituvio contains active ingredient Sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Zituvio is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Zituvio is not recommended in patients with type 1 diabetes mellitus. Zituvio has not been studied in patients with a history of pancreatitis.

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