1.) Recent 505 (b) (2) filings 2.) Delhi High Court case, Wow Momo Foods Private Limited vs. Wow Burger.
Contents Recent 505 (b) (2) filings General information GLP-1 Litigation and the Road Ahead for Independent Pharmacies Pharmacy groups defend Iowa PBM law amid legal challenge Intellectual Property Delhi High Court case, Wow Momo Foods Private Limited vs. Wow Burger. Recent 505 (b) (2) filings We follow 505 (b) (2) approvals every month. Generally, 505(b)(2) NDAs pertain to changes in comparison to previously approved drugs, such as indication, active ingredient, fixed-combination, dosage form, route of administration, dosing regimen, strength, and formulation (not approvable under section 505(j)). For more details on 505(b)(2) FDA approvals, please visit this link . The details of September 2025, 505 (b) (2)/NDA approvals are as follows: General information GLP-1 Litigation and the Road Ahead for Independent Pharmacies The GLP-1 era has moved from innovation to enforcement. Independent pharmacies that once played a critical role in meeting patient demand during shortages ...