Research Summary
Research Summary
10/01/2026
Ashton L. Stahl
A large US study found that two RSV prevention strategies, giving infants the antibody nirsevimab or vaccinating mothers during pregnancy, substantially reduced the risk of babies needing emergency or...
10/01/2026
FDA Approval
FDA Approval
09/18/2026
Anthony Calabro, MA
The FDA approval addresses acquired endocrine resistance by allowing eligible patients with HR-positive, HER2-negative advanced breast cancer to switch to camizestrant when an ESR1 mutation is detected in...
09/18/2026
Research Summary
Research Summary
09/15/2026
Anthony Calabro, MA
An updated systematic review of randomized, placebo-controlled trials found that long-term combined and estrogen-only hormone therapy may have different risk-benefit profiles for stroke, breast cancer,...
09/15/2026
FDA Approval
FDA Approval
08/10/2026
Anthony Calabro, MA
The FDA approved the norelgestromin and ethinyl estradiol transdermal system (Gwyn Lo, Viatris Inc), a once-weekly combined hormonal contraceptive patch, based on phase 3 data on efficacy, safety, and...
08/10/2026
Timelines
Notable FDA Approvals
Timelines
07/27/2026
July 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,...
07/27/2026
FDA Approval
FDA Approval
07/17/2026
Anthony Calabro, MA
The FDA approved gedatolisib with fulvestrant, with or without palbociclib, for adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected after...
07/17/2026
FDA Approval
FDA Approval
06/26/2026
Anthony Calabro, MA
The FDA approved sacituzumab govitecan-hziy (Trodelvy) as monotherapy, and with pembrolizumab-based therapy, for select adults with previously untreated unresectable locally advanced or metastatic...
06/26/2026
Clinical Guidance
Clinical Guidance
06/11/2026
Anthony Calabro, MA
ACOG’s 2026 maternal immunization schedule outlines vaccine recommendations before, during, and after pregnancy, including influenza, COVID-19, Tdap, and RSV vaccination.
06/11/2026
CONFERENCE COVERAGE
CONFERENCE COVERAGE
06/10/2026
Ashton L. Stahl
Researchers assessed whether GLP-1 exposure was associated with breast cancer incidence among women undergoing screening.
06/10/2026
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