FDA Alert
FDA Alert
05/22/2026
Anthony Calabro, MA
On May 22, 2026, the FDA approved datopotamab deruxtecan-dlnk for adults with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy, based on...
05/22/2026
FDA Alert
FDA Alert
05/21/2026
Anthony Calabro, MA
The FDA approved Enhertu for neoadjuvant treatment of adults with HER2-positive stage II or III breast cancer and adjuvant treatment of patients with residual invasive disease after neoadjuvant therapy. ...
05/21/2026
FDA Approval
FDA Approval
05/04/2026
Anthony Calabro, MA
On May 1, the FDA approved vepdegestrant (Veppanu), a heterobifunctional protein degrader, for adults with estrogen receptor–positive, human epidermal growth factor receptor 2–negative, ESR1-mutated...
05/04/2026
FDA Alert
FDA Alert
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
Public Health
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 ALERT
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
FDA Alert
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
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 Alert
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
FDA Alert
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