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
ASCO CONFERENCE COVERAGE
ASCO CONFERENCE COVERAGE
05/22/2026
Anthony Calabro, MA
In a phase 3 BWEL substudy, a lifestyle-based weight loss intervention improved patient-reported physical function, global health, social roles and activities, and fatigue in women with stage II-III breast...
05/22/2026
Research Summary
Research Summary
05/21/2026
Ashton L. Stahl
Phase 3 data evaluated whether relacorilant plus nab-paclitaxel improves survival in platinum-resistant ovarian cancer.
05/21/2026
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