Tag: FDA approval
Johnson & Johnson Secures FDA Approval for Dual-Energy Cardiac Ablation Catheter
Johnson & Johnson has secured U.S. regulatory clearance for its newest electrophysiology device, the Dual Energy THERMOCOOL SMARTTOUCH SF Platform. The system lets doctors...
FDA Approves Utebzi for Complicated Urinary Tract Infections
GSK plc and Spero Therapeutics announced that the US Food and Drug Administration (FDA) has approved Utebzi(tebipenem pivoxil). It is indicated for adult patients with complicated urinary tract...
FDA Grants Accelerated Approval to Sanofi’s Tzield® for Pediatric Stage 3 Type 1 Diabetes
The U.S. Food and Drug Administration has granted accelerated approval to Sanofi's Tzield® (teplizumab-mzwv) for children aged 8 to 17 years recently diagnosed with stage...
FDA Approves Wockhardt’s Novel Antibiotic ZAYNICH™️ for cUTI
Wockhardt Limited announced that the U.S. Food and Drug Administration (FDA) has approved ZAYNICH™ (cefepimeand zidebactam), a novel intravenous antibiotic for treating adults with complicated urinary...
AbbVie’s DECNUPAZ™ got Approval from FDA: First and Only Antibody-Drug Conjugate (ADC) Treatment
AbbVie (NYSE: ABBV) announced that the U.S. Food and Drug Administration (FDA) has approved DECNUPAZTM (pivekimab sunirine-pvzy), first and only antibody-drug conjugate (ADC) drug for the treatment of Blastic Plasmacytoid Dendritic Cell...
Bristol Myers Squibb Secures Dual Regulatory Wins for Opdivo® in Classical Hodgkin Lymphoma
Bristol Myers Squibb (NYSE: BMY) announced that Opdivo® (nivolumab) has received approval for two new classical Hodgkin Lymphoma (cHL) indications in the U.S. and...