FDA Approvals
FDA Approves Spikevax COVID Shot in Children at Increased Risk
The FDA approved Moderna’s COVID-19 vaccine, Spikevax, in children between the ages of 6 months and 11 years ...
JULY 15, 2025
FDA Approves Enflonsia, Second RSV Antibody for Infants
The FDA has approved the second monoclonal antibody for the prevention of RSV in neonates and infants, ...
JUNE 10, 2025
FDA Approves New Moderna COVID-19 Shot
The FDA has approved a new COVID-19 vaccine from Moderna, mNEXSPIKE (mRNA-1283).
JUNE 4, 2025
FDA Approves Vonoprazan for NERD
The FDA has approved vonoprazan (Voquenza, Phathom) 10-mg tablets for use in patients with nonerosive reflux ...
JULY 19, 2024
FDA Approves First Treatment for Molluscum Contagiosum
The FDA approved cantharidin (Ycanth/Verrica Pharmaceuticals), the first approved treatment for children and adults ...
JULY 24, 2023
FDA Approves First RSV Vaccine in U.S.
The first respiratory syncytial virus (RSV) vaccine, adjuvanted (Arexvy, GSK) has been approved for use in the ...
MAY 4, 2023
FDA Approves OTC Version of Opioid Overdose Reversal Agent
The FDA approved the OTC version of naloxone nasal spray to rapidly reverse the effects of opioid overdose.
MARCH 29, 2023
FDA Approves Rezzayo, a Novel Echinocandin
Rezzayo, a novel echinocandin, is indicated for the treatment of candidemia and invasive candidiasis in adults 18.
MARCH 23, 2023
Dengue Vaccine Approved for U.S. Endemic Regions
The FDA approved Dengvaxia, the first vaccine for preventing dengue disease caused by all dengue virus serotypes in ...
MAY 3, 2019
ID Drugs Approved in 2018
ID drugs had a good showing in 2018, mostly among HIV drugs and antibiotics.
DECEMBER 31, 2018
FDA Approves Xofluza for Influenza
Xofluza is indicated for the treatment of acute uncomplicated influenza in patients aged 12 years and older who ...
OCTOBER 24, 2018
FDA Approves Vosevi for Patients With Chronic HCV
The FDA has approved Vosevi, a single-tablet pangenotypic regimen for the treatment chronic HCV infection in adults ...
JULY 19, 2017
