Strides gets USFDA nod for Generic Suprep Bowel Prep Kit Ruchika Sharma23 Nov 2023 11:30 AM ISTThe company has set a target to launch ~ 60 new products over three years in the US.
Zydus, Dr Reddy's Labs and 1 other recall products in US over manufacturing issues Ruchika Sharma22 Nov 2023 3:56 PM ISTNew Delhi: Dr Reddy's Laboratories, Glenmark Pharma and Zydus are recalling products in the US market for manufacturing issues, according to the...
Lupin Dapagliflozin Tablets gets tentative USFDA okay Ruchika Sharma22 Nov 2023 1:30 PM ISTDapagliflozin Tablets are used for the treatment of type 2 diabetes.
Aurobindo Pharma USA arm, Evive Biotech bags USFDA nod for Ryzneuta for Chemotherapy-Induced Neutropenia Ruchika Sharma22 Nov 2023 12:30 PM ISTRyzneuta is a novel long-acting Granulocyte colonystimulating factor (G-CSF), which can stimulate the proliferation, differentiation, and release of...
Lupin gets USFDA nod for cholesterol lowering drug Pitavastatin Ruchika Sharma22 Nov 2023 11:37 AM ISTThe product will be manufactured at Lupin's Pithampur facility in India.
US FDA to delay decision on Bristol Myers-2seventy bio cancer therapy Ruchika Sharma21 Nov 2023 2:30 PM ISTThe therapy was originally co-developed by bluebird bio but following its spin-off in 2021 became part of 2seventy's portfolio.
Strides Pharma Science Singapore arm gets USFDA nod for Levetiracetam Oral Solution Ruchika Sharma21 Nov 2023 11:30 AM ISTIt is used in the treatment of seizures.
USFDA issues warning letter to Cipla Pithampur facility Ruchika Sharma20 Nov 2023 4:30 PM ISTMumbai: Cipla has announced that the Company has received a warning letter from the United States Food and Drug Administration (USFDA) for the...
Dr Reddy's Labs unveils USFDA-approved drug-free non-invasive migraine management device Nerivio in India Ruchika Sharma20 Nov 2023 3:29 PM ISTThe device uses the Remote Electrical Neuromodulation (REN) mechanism to specifically activate conditioned pain modulation by stimulating nerve...
Medtronic gets USFDA approval for minimally invasive device to treat hypertension Ruchika Sharma19 Nov 2023 1:00 PM ISTDublin: Medtronic plc, a global leader in healthcare technology, has announced that the United States Food and Drug Administration (FDA) has...
Truqap plus Faslodex approved in US for advanced HR-positive breast cancer: AstraZeneca Ruchika Sharma18 Nov 2023 2:14 PM ISTCambridge: AstraZeneca’s Truqap (capivasertib) in combination with Faslodex (fulvestrant) has been approved in the US for the treatment of adult...
USFDA concludes inspection at Aurobindo Pharma arm Unit I, III with zero observations Ruchika Sharma18 Nov 2023 12:30 PM ISTHyderabad: Aurobindo Pharma has announced that the United States Food and Drug Administration (US FDA) has closed the Pre-Approval Inspection (PAI)...
