regulatory review

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

3 weeks ago talkbio0Tagged agency staffing shortages, Amyotrophic Lateral Sclerosis, delays, narsoplimab, NUZ-001, Omeros Corporation, regulatory review, Study on Hold, Transplantation, United States Food and Drug Administration

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

CHMP Recommends Five New Drugs and Reviews Eli Lilly’s Kisunla

3 months ago talkbio0Tagged Biosimilars, CHMP, eli lilly, Hyperphosphatemia (disorder), Kisunla, Multiple Acyl Coenzyme A Dehydrogenase Deficiency, Myopia, regulatory review

CHMP; EMA; new drug approvals; Eli Lilly; Kisunla; biosimilars; hyperphosphatemia; myopia; March 2025; regulatory review

FDA Declines Approval for J&J’s Subcutaneous Rybrevant and AstraZeneca’s Full Approval Bid for Andexxa

9 months ago talkbio0Tagged Andexxa, AstraZeneca, J&J, regulatory review, Rybrevant, United States Food and Drug Administration

FDA, J&J, Rybrevant, AstraZeneca, Andexxa, regulatory review, pharmaceuticals