Organon

The European Medicines Agency has confirmed suicidal thoughts as a rare side effect of finasteride, a medication commonly used to treat male pattern hair loss in men aged 18-41.

Conduit Pharmaceuticals has filed groundbreaking patents for a dual active cocrystal formulation of tapinarof (VTAMA®), potentially addressing both inflammatory conditions and associated symptoms like pain and itch.

Daré Bioscience has unveiled a dual-path approach to make its proprietary Sildenafil Cream formulation available via prescription by Q4 2025, responding to healthcare community urging and women's demand.

Multiple pharmaceutical companies including Organon, Samsung Bioepis, Sandoz, and Boehringer Ingelheim launched Humira biosimilars in July 2023, offering significant price reductions compared to the original drug.

The FDA has approved 61 biosimilars across 17 molecules as of December 2024, with adalimumab biosimilars increasing market share from 2% to 24% throughout the year.

The FDA has approved Vtama (tapinarof) cream 1% for treating atopic dermatitis in adults and children aged 2 years and older.

The FDA has accepted Ionis Pharmaceuticals' NDA for donidalorsen, a potential prophylactic treatment for hereditary angioedema (HAE) in patients aged 12 and older.

The FDA has accepted the Biologic License Application (BLA) for HLX14, a proposed biosimilar to denosumab (PROLIA/XGEVA), developed by Shanghai Henlius Biotech and Organon.

• The FDA is considering removing oral phenylephrine from its OTC Monograph due to a lack of efficacy as a nasal decongestant, potentially impacting numerous cold and allergy products. • Novartis' Scemblix expands its FDA-approved uses to include the treatment of newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ PML). • Astellas Pharma's Vyloy (zolbetuximab) receives FDA approval as the first treatment targeting the CLDN18.2 protein for gastric or gastroesophageal junction adenocarcinoma. • Iterum Therapeutics' Orlynvah (sulopenem) gains FDA approval for treating uncomplicated urinary tract infections in women with limited oral antibacterial treatment options.

Organon's aBLA for HLX14, a proposed biosimilar of Amgen's Prolia®/Xgeva® (denosumab), has been accepted by the FDA, marking a step toward alternative treatment options.