HER2-mutated non-small cell lung cancer (NSCLC) is a rapidly emerging segment, garnering intense interest from oncologists, patients, and pharma industry innovators. With the FDA’s accelerated approval of Hernexeos zongertinib, the landscape for HER2-driven NSCLC has fundamentally shifted—ushering in new hope for…
On August 6, 2025, the U.S. Food and Drug Administration (FDA) granted accelerated approval to MODEYSO (dordaviprone), a first-in-class protease activator for adult and pediatric patients aged one year and older with H3 K27M-mutant diffuse midline glioma (DMG) that has…
On 2025-07, the U.S. Food and Drug Administration (FDA) approved VIZZ aceclidine ophthalmic solution 1.44%, a first-in-class topical therapy for presbyopia [1]. Developed by LENZ Therapeutics, Inc., VIZZ is a novel cholinergic muscarinic agonist that offers a non-surgical, pharmacological approach…
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…