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FDA Alerts

Timeline Snapshot
timeline snapshot
Timeline Snapshot
Notable FDA Approvals in June
06/29/2026
June 2026 included several FDA drug and biologic approvals across a range of therapeutic areas. This timeline highlights the key alerts our publication covered throughout the month, giving readers a quick,...
06/29/2026
FDA Approval
woman getting a shot
FDA Approval
Ensitrelvir (Xocova) Receives FDA Approval for COVID-19 Post-Exposure Prophylaxis
06/23/2026
Anthony Calabro, MA
The FDA approved ensitrelvir (Xocova) for post-exposure prophylaxis of COVID-19 in adults and adolescents aged 12 years and older following contact with an individual with COVID-19.
06/23/2026
Public Health
Data from CDC
Public Health
COVID-19 Booster No Longer Recommended for Healthy Children, Pregnant People
05/28/2025
Kate Young
Secretary Robert F. Kennedy Jr. announced that the CDC will no longer recommend the COVID-19 booster vaccine for healthy children and pregnant people. The announcement comes despite previous CDC...
05/28/2025
FDA Alert
FDA building
FDA Alert
FDA Limits COVID-19 Vaccine Access to People 65 and Older, High-Risk Populations
05/20/2025
Kate Young
The FDA has announced that it will limit access to COVID-19 vaccines, making them only available to high-risk populations. The organization also announced that they will require manufacturers to further...
05/20/2025
FDA Alert
fda alerts
FDA Alert
As Infections Increase, FDA Approves Updated Vaccines to Protect Against COVID-19 Variants
09/15/2023
Anthony Calabro, MA
The FDA approved the new round of vaccines for those 12 years and older and authorized emergency use for children 6 months to 11 years of age.
09/15/2023
FDA Alert
fda alerts
FDA Alert
As Infections Increase, FDA Approves Updated Vaccines to Protect Against COVID-19 Variants
09/15/2023
Anthony Calabro, MA
The FDA approved the new round of vaccines for those 12 years and older and authorized emergency use for children 6 months to 11 years of age.
09/15/2023
FDA alert
fda
FDA alert
FDA Approves the First RSV Vaccine For Use in United States
05/04/2023
Jessica Ganga
After an ongoing study, the FDA approves the first vaccine for the highly contagious respiratory virus for us in the United States.
05/04/2023
Vaccination
Vaccination
FDA Approves Second COVID-19 Vaccine
02/01/2022
The US Food and Drug Administration has approved a second vaccine for the prevention of COVID-19.
02/01/2022
Vaccination
Vaccination
FDA Authorizes COVID-19 Booster Dose in Certain Populations
09/23/2021
The US Food and Drug Administration has approved a booster dose of the Pfizer-BioNTech COVID-19 vaccine in certain patient populations.
09/23/2021
vaccination
vaccination
FDA Fully Approves First COVID-19 Vaccine
08/23/2021
After an in-depth analysis and review of the data, the US Food and Drug Administration has fully approved the first COVID-19 vaccine for individuals aged 16 years or older.
08/23/2021