- In February 2023, Aldeyra Therapeutics, Inc. announced the commencement of Phase 2 clinical trials to assess the safety and efficacy of ADX-629, an innovative oral RASP modulator developed in-house. This investigational treatment targets both minimal change disease and Sjogren-Larsson Syndrome. Additionally, Aldeyra revealed plans to expand the minimal change disease trial to include idiopathic nephrotic syndrome, which encompasses a range of rare, immune-mediated kidney disorders, further broadening the scope of their research
- In November 2022, Alembic Pharmaceuticals obtained final approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Cyclophosphamide Capsules, available in 25 mg and 50 mg dosages. This approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Cyclophosphamide Capsules, produced by Hikma Pharmaceuticals USA Inc. Cyclophosphamide is an alkylating agent indicated for treating malignant diseases as well as minimal change nephrotic syndrome in pediatric patients, highlighting its significance in pediatric nephrology
