Medtronic bags USFDA nod for PulseSelect Pulsed Field Ablation System to treat atrial fibrillation Ruchika Sharma14 Dec 2023 12:30 PM ISTThe PulseSelect PFA system was engineered with differentiated safety features and provides rapid, effective pulmonary vein isolation through...
USFDA inspection: Laurus Labs arm gets 5 observations for AP facility Ruchika Sharma13 Dec 2023 11:18 AM ISTHyderabad: Laurus Synthesis Private Limited (LSPL), a wholly owned subsidiary of Laurus Labs, has received a Form 483 with five observations...
Torrent Pharma gets 5 USFDA observations for Gujarat facility Ruchika Sharma12 Dec 2023 1:06 PM ISTAhmedabad: Torrent Pharma has announced that the United States Food and Drug Administration (USFDA) has concluded the inspection with 5 procedural...
Pfizer Marstacimab regulatory submissions for treatment of Hemophilia A and B accepted by USFDA, EMA Ruchika Sharma12 Dec 2023 11:28 AM ISTThe submissions for marstacimab are based on efficacy and safety data from the Phase 3 BASIS trial.
Intas Pharma gets USFDA warning letter due to manufacturing lapses at Ahmedabad plant Ruchika Sharma11 Dec 2023 11:30 AM IST"Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate," USFDA said.
Dr Reddy's Labs gets 3 USFDA observations for Bachupally RnD centre Ruchika Sharma9 Dec 2023 10:57 AM ISTHyderabad: Drug major Dr Reddy's Labs, has announced that the United States Food & Drug Administration (USFDA) has issued three...
USFDA accepts for priority review Bristol Myers Squibb application for Opdivo plus Cisplatin-Based Chemotherapy for urothelial carcinoma Ruchika Sharma7 Dec 2023 12:30 PM ISTPrinceton: Bristol Myers Squibb has announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License...
Novartis gets USFDA nod for Fabhalta for adults with paroxysmal nocturnal hemoglobinuria Ruchika Sharma7 Dec 2023 11:43 AM ISTBasel: Novartis has announced that the U.S. Food and Drug Administration (FDA) has approved Fabhalta (iptacopan) as the first oral monotherapy for the...
Indoco Remedies Canagliflozin Tablets for type 2 diabetes adults get USFDA tentative okay Ruchika Sharma6 Dec 2023 5:01 PM ISTCanagliflozin improves glycemic control in adults with type 2 diabetes mellitus.
Zydus Lifesciences gets USFDA okay for acquired methemoglobinemia injection Methylene Blue Ruchika Sharma6 Dec 2023 3:30 PM ISTMethylene Blue Injection is an oxidation-reduction agent indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia.
Lupin bags USFDA nod for Varenicline Tablets for smoking cessation treatment Ruchika Sharma6 Dec 2023 11:30 AM ISTVarenicline Tablets, 0.5 mg and 1 mg are indicated for use as an aid to smoking cessation treatment.
JnJ gets USFDA breakthrough therapy designation for TAR 200 for bladder cancer treatment Ruchika Sharma5 Dec 2023 11:27 AM ISTTAR-200 is a novel investigational targeted releasing system designed to provide sustained local release of gemcitabine into the bladder.
