Regulatory Filing

Zymeworks Pivots to Royalty-Driven Model After Strong Ziihera Data in Gastric Cancer

3 weeks ago talkbio0Tagged Biological Factors, buyback, erbB-2 Receptor, Jazz, Malignant neoplasm of stomach, milestone payments, Regulatory Filing, Royalty-Driven Model, Strategy, Ziihera, Zymeworks

Zymeworks; royalty-driven model; Ziihera; gastric cancer; HER2; biologics; milestone payments; stock buyback; biotech strategy; Jazz Pharmaceuticals; regulatory filing

GSK, Spero Reveal Full Phase 3 Data for Oral Antibiotic Tebipenem HBr; Regulatory Filing Set for End of 2025

2 months ago talkbio0Tagged Complicated, cUTIs, HBr, IDWeek, non-inferiority, oral carbapenem, Phase 3 PIVOT-PO trial, Regulatory Filing, SmithKline Beecham, Spero Therapeutics, Submission, United States Food and Drug Administration, Urinary tract infection

GSK; Spero Therapeutics; tebipenem HBr; oral carbapenem; Phase 3 PIVOT-PO trial; complicated urinary tract infections (cUTIs); non-inferiority; IDWeek 2025; regulatory filing; FDA submission

Milestone’s Etripamil Nasal Spray Advances Towards Regulatory Filing in China for PSVT Treatment

1 year ago talkbio0Tagged Cardiovascular system, China, etripamil nasal spray, Milestone, Paroxysmal, Paroxysmal supraventricular tachycardia, Pharmaceuticals Ltd, Regulatory Filing, Tenascin, human

Etripamil nasal spray, Paroxysmal supraventricular tachycardia (PSVT), Milestone Pharmaceuticals, Ji Xing Pharmaceuticals Ltd, China regulatory filing, Cardiovascular therapies