Drug Approval | October 01, 2025
AbbVie seeks FDA approval for Pivekimab Sunirine to treat rare, aggressive blood cancer
BPDCN is a challenging blood cancer with characteristics of both leukemia and lymphoma
BPDCN is a challenging blood cancer with characteristics of both leukemia and lymphoma
FDA authorization was based on two years of clinical study data demonstrating that Essilor Stellest lenses significantly slowed myopia progression compared to single-vision control lenses
An estimated 50% of patients with ER+, HER2– metastatic breast cancer will develop an ESR1 mutation during or after exposure to an aromatase inhibitor
If approved, tavapadon will enhance AbbVie's leadership in Parkinson's disease by providing patients with a once daily oral treatment option
Paroxetine Extended-Release Tablets USP, 25 mg and 37.5 mg, are indicated for the treatment of major depressive disorder
Bictegravir, Emtricitabine, and Tenofovir Alafenamide Tablets are indicated for the treatment of human immunodeficiency virus infection in adults and pediatric patients weighing at least 25 kg
Agency initiates safety label change and notifies physicians of possible link
Keytruda Qlex is the first and only subcutaneously administered immune checkpoint inhibitor that can be given by a health care provider in as little as one minute
The inspection concluded with zero form 483 observations
IND application for EB-003 expected in early 2026
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