Merck gets USFDA nod for KEYTRUDA as adjuvant treatment for non-small cell lung cancer Ruchika Sharma30 Jan 2023 2:45 PM ISTKEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body's immune system to help detect and...
USFDA concludes inspection at Solara Active Pharma Sciences Vizag facility with Zero 483 inspectional observations Ruchika Sharma30 Jan 2023 11:25 AM ISTBengaluru: Solara Active Pharma Sciences Ltd has announced that its new state-of-the-art multipurpose API manufacturing facility at...
USFDA gives exception to Glenmark Pharma to supply pneumonia drug Atovaquone oral suspension from Baddi facility Ruchika Sharma28 Jan 2023 2:15 PM ISTAtovaquone oral suspension is indicated for the treatment of mild to moderate Pneumocystis pneumonia.
USFDA issues zero observations for Gland Pharma Visakhapatnam API facility Ruchika Sharma28 Jan 2023 1:00 PM ISTVisakhapatnam: Gland Pharma has recently announced that the company has received zero observations from the US Food and Drug Administration (USFDA)...
Zydus Lifesciences gets zero USFDA observations for Moraiya facility Ruchika Sharma28 Jan 2023 12:28 PM ISTAhmedabad: Zydus Lifesciences Limited has recently announced that the US Food and Drug Administration (USFDA) has concluded a Pre-Approval Inspection...
USFDA withdraws emergency use authorization for AstraZeneca COVID 19 treatment Evusheld Ruchika Sharma27 Jan 2023 4:42 PM ISTAstraZeneca said it was informed that the agency will decide about reinstating authorization of Evusheld if the prevalence of resistant variants in...
USFDA joins global regulators probing tainted overseas cough syrup Ruchika Sharma27 Jan 2023 3:30 PM ISTNew York: The US Food and Drug Administration said on Wednesday it is working with the World Health Organisation and foreign regulatory authorities to...
Macleods Pharma recalls 10000 bottles of anti bacterial medication in US over labelling error Ruchika Sharma27 Jan 2023 11:30 AM ISTNew Delhi: Macleods Pharmaceuticals is recalling around 10,000 bottles of generic antibiotic medication in the US market due to a labelling...
Torrent Pharma gets USFDA OAI status for Gujarat facility Ruchika Sharma24 Jan 2023 3:14 PM ISTAhmedabad: Torrent Pharma has announced that the Company has received a communication from the US Food and Drug Administration (USFDA)...
USFDA inspection: Indoco Remedies gets 9 observations for Goa facility Ruchika Sharma24 Jan 2023 2:30 PM ISTMumbai: Indoco Remedies has announced that the United States Food and Drug Administration (USFDA) has issued 9 observations after GMP...
Granules Pharma bags USFDA nod for ADHD drug Amphetamine Mixed Salts ER Ruchika Sharma24 Jan 2023 12:02 PM ISTMixed Salts of a Single-Entity Amphetamine ER Capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
USFDA accepts supplemental New Drug Application for Jardiance for adults with chronic kidney disease: Eli Lilly Ruchika Sharma22 Jan 2023 12:00 PM ISTIndianapolis: The U.S. Food and Drug Administration (USFDA) has accepted a supplemental New Drug Application (sNDA) for Jardiance (empagliflozin)...
