FDA warns Bethesda, MD-based Longhorn Vaccines and Diagnostics about Quality System, Medical Device Reporting, and Adulterated and Misbranded Device violations in its work as a specification developer.
FDA asks to look at Rezolute’s Phase 3 data after the company’s trial of ersodetug missed the primary endpoint, with the hope of charting a clear path forward for the stalled program.
FDA warns Bethesda, MD-based Longhorn Vaccines and Diagnostics about Quality System, Medical Device Reporting, and Adulterated and Misbranded Device violations in its work as a specification developer.
FDA asks to look at Rezolute’s Phase 3 data after the company’s trial of ersodetug missed the primary endpoint, with the hope of charting a clear path forward for the stalled program.
Quoin Pharmaceuticals says FDA has signaled openness to a streamlined development path for its rare disease candidate QRX003, indicating that a single Phase 3 trial could be sufficient to support approval in Netherton Syndrome.
Beam Therapeutics says it will advance its base-editing therapy BEAM-302 into pivotal development to seek accelerated approval for treating Alpha-1 Antitrypsin.
