JB Pharma secures USFDA nod for anxiety drug Ruchika Sharma24 Aug 2023 12:30 PM ISTThe drug will be manufactured at JB Pharma's formulation manufacturing facility in Panoli, Gujarat.
Concord Biotech gets USFDA EIR for Limbasi facility Ruchika Sharma23 Aug 2023 3:30 PM ISTAhmedabad: Through a recent BSE filing, Concord Biotech Limited has notified that the Company has received the Establishment Inspection...
Marksans Pharma Mucus loosening drug Guaifenesin ER bags USFDA okay Ruchika Sharma22 Aug 2023 4:50 PM ISTGuaifenesin extended-release tablets help to loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus...
USFDA places partial clinical hold on Magrolimab studies in acute myeloid leukemia: Gilead Sciences Ruchika Sharma22 Aug 2023 12:30 PM ISTMagrolimab is a potential first-in-class investigational anti-CD47 immunotherapy.
Pfizer maternal vaccine Abrysvo bags USFDA approval for RSV prevention in infants Ruchika Sharma22 Aug 2023 11:26 AM ISTNew York: Pfizer Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved ABRYSVO (Respiratory Syncytial Virus Vaccine),...
No concerns about Medtronic, Otsuka BP devices raised by USFDA staff Ruchika Sharma21 Aug 2023 2:30 PM ISTThe staff reviewers said the available safety data for the device made by ReCor, a unit of Otsuka Holdings, did not raise concerns, while pointing...
Regeneron Pharma Eylea HD injection approved by USFDA for treatment of Wet age-related macular degeneration, diabetic macular edema, diabetic retinopathy Ruchika Sharma21 Aug 2023 1:30 PM ISTTarrytown: Regeneron Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved EYLEA HD...
Regeneron Pharma secures USFDA okay for Veopoz for children, adults with Chaple disease Ruchika Sharma19 Aug 2023 11:40 AM ISTVeopoz, a fully human monoclonal antibody, is designed to target complement factor C5, a protein involved in complement system activation.
New postpartum depression pill could be game changer Roshni Dhar17 Aug 2023 5:03 PM ISTThe U.S. Food and Drug Administration has approved Zurzuvae (zuranolone), the first oral medication indicated to treat postpartum depression (PPD) in...
Recall of Philips respiratory devices classified as most serious by USFDA Ruchika Sharma17 Aug 2023 2:30 PM ISTThe ventilators being recalled include Trilogy Evo, Evo O2 and EV300, among others.
USFDA tentative nod to Aurobindo Pharma's generic FDC drug to treat HIV in children Ruchika Sharma17 Aug 2023 1:30 PM ISTAurobindo has capacities in their FDA approved plant to meet the market demand for this product and commercial production will commence in Q3 FY24.
Lupin wins USFDA nod for Bromfenac Ophthalmic Solution Ruchika Sharma17 Aug 2023 11:00 AM ISTMumbai: Global pharma major Lupin Limited has announced that the company has received approval from the United States Food and Drug Administration...
