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FDA Alerts

FDA Alert
FDA Alert
FDA Alert
HHS, FDA Initiate Removal of Black Box Warning on Hormone Therapy Products for Menopause
11/26/2025
Kate Young
On November 10, the U.S. Department of Health and Human Services announced that the FDA is initiating the removal of certain black box warnings from hormone replacement therapy products for menopause,...
11/26/2025
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
chemo
FDA ALERT
FDA Approves Pembrolizumab With Chemotherapy to Treat Primary Advance or Recurrent Endometrial Carcinoma in Patients
09/13/2024
Jessica Ganga
In June, following a placebo-controlled trial, the FDA approved pembrolizumab with chemotherapy to treat patients with primary advanced or recurrent endometrial carcinoma.
09/13/2024
FDA Alert
shutterstock
FDA Alert
FDA Approves First Dissolvable Birth Control Pill
07/31/2024
Anthony Calabro, MA
The first orally disintegrating birth control tablet was designed for individuals who have trouble swallowing their medication.
07/31/2024
FDA Alert
Fda alert
FDA Alert
FDA Approves First Oral Medication for Treatment of Postpartum Depression
10/04/2023
Jessica Ganga
Following two randomized studies, the FDA has approved zuranolone for the treatment of postpartum depression in adults—the first if its kind.
10/04/2023
FDA Alert
fda
FDA Alert
FDA Approves First RSV Vaccine For Pregnant Individuals
08/24/2023
Anthony Calabro, MA
Earlier this year, the FDA approved the same vaccine for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older.
08/24/2023
FDA Alert
pills
FDA Alert
FDA Approves First Over-The-Counter, Nonprescription Daily Oral Contraceptive
07/21/2023
Jessica Ganga
The FDA has approved the first daily oral contraceptive for the prevention of pregnancy that does not require a health care provider’s prescription.
07/21/2023
fda alert
fda
fda alert
FDA Approves Novel Treatment for Menopausal Hot Flashes
06/07/2023
Leigh Precopio
The US FDA recently approved a novel treatment for moderate to severe vasomotor symptoms that are caused by menopause.
06/07/2023
FDA
FDA
FDA Approves New Option for Early Stage Breast Cancer
07/18/2017
The US Food and Drug Administration recently approved a new treatment option for patients with early stage HER2-overexpressed/amplified breast cancer. For recommended dosage and common adverse events, read...
07/18/2017
FDA
FDA
FDA Expands Indication for Metastatic Breast Cancer Treatment
04/03/2017
The FDA converted Ibrance to regular FDA approval and approved a supplemental New Drug Application for the drug, broadening its range of antihormonal therapy.
04/03/2017