Granules India subsidiary bags USFDA nod for Sildenafil for Oral Suspension Ruchika Sharma4 Dec 2023 1:30 PM ISTSildenafil for Oral Suspension is indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in...
Merck application for Keytruda plus Padcev for Urothelial Cancer gets USFDA priority review Ruchika Sharma2 Dec 2023 2:30 PM ISTRahway: Merck, known as MSD outside of the United States and Canada, has announced that the U.S. Food and Drug Administration (FDA) has accepted...
Eli Lilly secures USFDA nod for leukemia treatment Jaypirca Ruchika Sharma2 Dec 2023 1:30 PM ISTThis is the second FDA-approved indication for Jaypirca following the January 2023 Accelerated Approval for the treatment of adult patients with...
Lupin unveils generic contraceptive drug in US Ruchika Sharma2 Dec 2023 12:30 PM ISTMumbai: Global pharma major Lupin Limited has announced the launch of Turqoz (Norgestrel and Ethinyl Estradiol) Tablets USP, 0.3 mg/0.03 mg, after...
USFDA issues 3 observations for Alkem Labs Mandva facility Ruchika Sharma2 Dec 2023 11:32 AM ISTMumbai: Through a recent BSE filing, Alkem Labs has informed that the Company has received Form 483 with three observations from the United...
Zydus Lifesciences gets USFDA nod for heart failure drug Ivabradine Ruchika Sharma1 Dec 2023 2:36 PM ISTThe drug will be manufactured at the group's formulation manufacturing facility at Ahmedabad SEZ, India.
Aurobindo Pharma arm gets USFDA nod for Budesonide Inhalation Suspension for asthma Ruchika Sharma30 Nov 2023 12:20 PM ISTBudesonide Inhalation Suspension, 0.5 mg/2 mL Single-Dose Ampule is indicated for maintenance treatment of asthma and as prophylactic therapy in...
Aurobindo Pharma bags USFDA nod for HIV drug Darunavir Ruchika Sharma29 Nov 2023 2:46 PM ISTHyderabad: Aurobindo Pharma Limited has announced that the Company has received final approval from the US Food & Drug Administration (USFDA) to...
Safety issue with Philips sleep apnea machines: USFDA alerts patients Ruchika Sharma29 Nov 2023 11:30 AM ISTThe U.S. Food and Drug Administration said on Tuesday that it is alerting patients about a safety issue with Dutch healthcare technology company...
Gland Pharma gets USFDA EIR for Pashamylaram facility Ruchika Sharma25 Nov 2023 11:48 AM ISTHyderabad: Gland Pharma has recently announced that the Company has received an Establishment Inspection Report (EIR) from the US FDA indicating the...
USFDA approves Lupin Bromfenac Ophthalmic Solution Ruchika Sharma24 Nov 2023 12:30 PM ISTBromfenac Ophthalmic Solution, 0.07% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have...
Lupin type 2 diabetes drug Canagliflozin bags USFDA tentative approval Ruchika Sharma24 Nov 2023 11:30 AM ISTMumbai: Global pharma major Lupin Limited has announced that it has received tentative approval from the United States Food and Drug Administration...
