FDA Delays Draw Contrasting Responses: Neurizon Cites Agency Strain, Omeros Takes Softer Tone

FDA delays; Neurizon Therapeutics; Omeros Corporation; regulatory review; NUZ-001; narsoplimab; ALS; transplant drugs; agency staffing shortages; clinical hold

HHS Revives ’90s-Era Task Force to Improve Childhood Vaccine Safety

HHS; childhood vaccines; vaccine safety; task force; Robert F. Kennedy Jr.; Jay Bhattacharya; NIH; FDA; CDC; vaccine oversight; adverse reactions; childhood immunization schedule

Precigen Receives FDA Approval for First Immunotherapy for HPV-Related Recurrent Respiratory Papillomatosis

Precigen; FDA approval; Papzimeos; zopapogene imadenovec-drba; HPV; recurrent respiratory papillomatosis (RRP); immunotherapy; gene therapy; adenoviral vector; Breakthrough Therapy designation

Eli Lilly Vows Vigorous Defense as Texas Sues Over Alleged Drug Kickbacks

Eli Lilly; Texas Attorney General; kickback scheme; drug prescriptions; Mounjaro; Zepbound; GLP-1 drugs; Medicaid fraud; Free Nurse Program; Support Services Program; Ken Paxton; pharmaceutical litigation

After CDC shooting, employees and public health leaders urge RFK Jr. to change his rhetoric

CDC shooting; RFK Jr. rhetoric; vaccine misinformation; CDC employee reactions; public health leaders; security measures; Atlanta CDC campus; Officer David Rose; HHS leadership; workplace safety

Bayer-allied NextRNA Therapeutics winds down operations after missing a milestone in their collaboration

NextRNA Therapeutics; Bayer; lncRNA; long non-coding RNA; oncology; biotech wind-down; missed milestone; Massachusetts biotech; seed and Series A funding; Dana-Farber; Carl Novina; 2025 biotech shutdowns

Novartis plans global filings after ianalumab hits primary endpoints in two Phase 3 Sjögren’s disease trials

Novartis; ianalumab; BAFF‑R; B-cell depletion; Sjögren’s disease; NEPTUNUS-1; NEPTUNUS-2; ESSDAI; Phase 3; regulatory filings; first targeted treatment; safety profile