Lupin bags tentative USFDA approval for Rivaroxaban Tablets Ruchika Sharma24 Jan 2024 11:19 AM ISTThis product will be manufactured at Lupin's Pithampur facility in India.
Indoco Remedies gets USFDA EIR for oral dosage facility at Goa plant I Ruchika Sharma23 Jan 2024 2:59 PM ISTMumbai: Indoco Remedies Limited has received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (U.S. FDA) for...
USFDA approves expanded MRI labelling for Abbott Proclaim DRG neurostimulation system for people suffering from chronic pain Ruchika Sharma23 Jan 2024 10:00 AM ISTAbbott Park, Ill.: Abbott has announced that the U.S. Food and Drug Administration (FDA) has approved expanded MRI labeling for its dorsal root...
USFDA adds boxed warning for Amgen bone loss drug Prolia Ruchika Sharma22 Jan 2024 2:30 PM ISTNew Delhi: The U.S. Food and Drug Administration added a serious warning on the prescribing information for Amgen's drug Prolia to treat bone...
JnJ Balversa gets full USFDA nod to treat locally advanced or metastatic Bladder Cancer with Select Genetic Alterations Ruchika Sharma21 Jan 2024 4:30 PM ISTRaritan: Johnson & Johnson has announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application...
USFDA finds new manufacturing lapses at Eli Lilly plant: Report Ruchika Sharma21 Jan 2024 4:00 PM ISTU.S. inspectors recently uncovered new manufacturing problems at an Eli Lilly plant that has been under scrutiny by federal investigators, according...
Lupin bags USFDA nod for hyperuricemia treatment drug Febuxostat Ruchika Sharma19 Jan 2024 1:30 PM ISTMumbai: Global pharma major Lupin Limited has announced that the Company has received approval from the United States Food and Drug...
USFDA updates Sanofi Dupixent label for atopic dermatitis Ruchika Sharma18 Jan 2024 3:00 PM ISTParis: Sanofi has announced that the U.S. Food and Drug Administration (FDA) has updated the label for Dupixent (dupilumab) in atopic dermatitis,...
Zydus Lifesciences secures USFDA nod for Pimavanserin capsules, tablets Ruchika Sharma18 Jan 2024 11:40 AM ISTBoth the tablets and the capsules will be manufactured at the group's formulation manufacturing facility at Ahmedabad SEZ, India.
Takeda Hyqvia gets USFDA nod for Chronic Inflammatory Demyelinating Polyneuropathy Ruchika Sharma17 Jan 2024 3:54 PM ISTOsaka: Takeda has announced that the U.S. Food and Drug Administration (FDA) has approved HYQVIA [Immune Globulin Infusion 10% (Human) with...
Lupin bags USFDA nod for hypertension drug Propranolol Hydrochloride ER Ruchika Sharma15 Jan 2024 11:48 AM ISTMumbai: Global pharma major Lupin Limited has announced that it has received approval from the United States Food and Drug Administration (U.S....
EU regulator starts safety review of CAR-T cancer cell therapies Ruchika Sharma15 Jan 2024 9:00 AM ISTThe European Union's drug watchdog has said it had started a review into the safety risks associated with cancer cell therapies made by companies such...
