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 Approval
FDA Approval
04/23/2026
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.
04/23/2026
Timeline Snapshot
physicians looking at ipad
Timeline Snapshot
04/16/2026
March 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,...
04/16/2026
FDA Alert
FDA Alert
08/19/2024
Anthony Calabro, MA
The nasal spray is the first FDA-approved epinephrine product for the treatment of anaphylaxis not to be administered by injection.
08/19/2024
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
09/28/2023
Anthony Calabro, MA
The FDA approved the second over-the-counter nasal spray with the goal of increasing access to products that can rapidly reverse the effects of opioid overdose.
09/28/2023