Generic Drug Program Activity Report FY 2025 by US FDA and Case: Ipsen Biopharm Ltd vs Sandoz AG et al
Contents Generic Drug Program Activity Report FY 2025 by US FDA. General information Novartis settles with Henrietta Lacks’ estate over use of her ’stolen’ cells to advance medicine Can Pharma Companies Reverse String of Judicial Defeats at SCOTUS? Intellectual Property Ipsen Biopharm Ltd vs Sandoz AG et al Generic Drug Program Activity Report FY 2025 by US FDA. FDA publishes Generic Drugs Program Activities Report. The FY 2025 report was recently published. The details can be found here . The FDA’s Fiscal Year 2025 Generic Drugs Program Activities Report reveals a highly active year for regulatory submissions, totalling 600 original Abbreviated New Drug Application (ANDA) receipts. Activity peaked significantly in September 2025, which saw 114 ANDA submissions—nearly double the monthly average. Beyond original applications, the program managed a massive volume of supplemental filings, including 11,715 total supplements and 2,087 amendments. * = Original Receipts are reported a...
