SEPHIENCE (sepiapterin) is a novel phenylalanine hydroxylase (PAH) activator that has received approval for treating hyperphenylalaninemia (HPA) in adult and pediatric patients (1 month and older) with sepiapterin-responsive Phenylketonuria (PKU). Patients take SEPHIENCE as a once-daily oral powder with food…
Hereditary angioedema (HAE) is a rare and potentially life-threatening condition that causes unpredictable swelling in the skin, gastrointestinal tract, and airways. For years, on-demand HAE treatments were limited to injectable options — delaying symptom relief for many patients. In July…
The recent FDA approval of ANZUPGO delgocitinib cream 2% is a genuinely pivotal moment in how we manage moderate-to-severe Chronic Hand Eczema (CHE). For the first time, we have a topical therapy specifically developed and approved for this challenging condition.…
This comprehensive article provides an in-depth analysis of ZEGFROVY™ (sunvozertinib), a recently FDA-approved kinase inhibitor, drawing insights from its official prescribing information and briefing documents. Tailored for healthcare professionals and informed pharmaceutical stakeholders in both India and the United States,…
Multiple myeloma, a complex and challenging hematologic malignancy, continues to pose significant therapeutic hurdles, particularly for patients with relapsed or refractory disease. Despite advancements in treatment, a substantial unmet need persists for patients who have exhausted conventional therapeutic avenues. The…
For those living with the constant uncertainty of hereditary angioedema (HAE), a significant breakthrough has arrived. A new treatment, Andembry® (garadacimab-gxii), was recently approved by the U.S. Food and Drug Administration (FDA) on June 16, 2025, offering a powerful new…
Ibtrozi™ (taletrectinib) is a next-generation, oral ROS1 tyrosine kinase inhibitor (TKI), approved by the U.S. FDA on June 11, 2025. It’s designed to treat adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors harbor ROS1…
The U.S. Food and Drug Administration (FDA) has approved ENFLONSIA (clesrovimab-cfor), a groundbreaking preventive monoclonal antibody developed by Merck (MSD outside the U.S. and Canada). This single-dose injectable therapy offers seasonal protection against Respiratory Syncytial Virus (RSV) — a major…
Dry Eye Disease (DED) is a prevalent condition affecting millions worldwide, characterized by insufficient or poor-quality tears leading to ocular discomfort and visual disturbances. On May 28, 2025, the U.S. Food and Drug Administration (FDA) approved Tryptyr™ (acoltremon ophthalmic solution)…
Lung cancer, particularly non-small cell lung cancer (NSCLC), remains one of the deadliest malignancies worldwide. Despite recent therapeutic advancements, many patients with advanced disease still face limited options—especially after failure of first-line systemic therapy. EMRELIS for NSCLC(telisotuzumab vedotin-tllv), a novel…