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
FDA Approval
FDA Approval
06/25/2026
Anthony Calabro, MA
The FDA approved expanded adjuvant therapy options for adults with renal cell carcinoma with a clear cell component who are at intermediate-high or high risk of recurrence after nephrectomy, with or without...
06/25/2026
FDA Approval
FDA Approval
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
FDA Approval
FDA Approval
05/13/2026
Anthony Calabro, MA
The FDA approved a once-daily, 2-drug oral regimen for adults with virologically suppressed HIV-1 to replace existing antiretroviral therapy.
05/13/2026
FDA Alert
FDA Alert
03/03/2026
Anthony Calabro, MA
On March 3, 2026, the FDA approved the first generic of Flovent HFA (fluticasone propionate) inhalation aerosol, 44 mcg per actuation, for the maintenance treatment of asthma as prophylactic therapy in...
03/03/2026
FDA Alert
FDA Alert
01/28/2025
Anthony Calabro, MA
The FDA is seeking a cap on nicotine levels in cigarettes and certain tobacco products at minimally or nonaddictive levels. This initiative, if finalized, would be what the FDA calls a “significant step”...
01/28/2025