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Tag: US Food and Drug Administration

You Searched For "US Food and drug administration"
Worlds most expensive drug: USFDA nod to HEMGENIX worth USD 3.5 million a dose

World's most expensive drug: USFDA nod to HEMGENIX worth USD 3.5 million a dose

Roshni Dhar25 Nov 2022 12:11 PM GMT
Global biotechnology leader CSL has announced that the U.S. Food and Drug Administration (USFDA) has approved HEMGENIX (etranacogene...
Tzield, first drug to delay type 1 diabetes onset, receives FDA approval

Tzield, first drug to delay type 1 diabetes onset, receives FDA approval

Medha Baranwal19 Nov 2022 5:45 AM GMT
TZIELD is the first disease-modifying therapy for type 1 diabetes, a life-threatening autoimmune disease.USA: Tzield (teplizumab-mzwv), an injection...
USFDA Commissioner Dr Robert M Califf tests COVID positive

USFDA Commissioner Dr Robert M Califf tests COVID positive

Ruchika Sharma8 Nov 2022 10:00 AM GMT
US: The U.S. Food and Drug Administration said on Monday that Commissioner Dr. Robert M. Califf tested positive for COVID-19 over the weekend while...
Aurobindo Pharma subsidiarys plant gets one observation from USFDA

Aurobindo Pharma subsidiary's plant gets one observation from USFDA

Kajal Rajput30 Aug 2022 6:53 AM GMT
Hyderabad: Aurobindo Pharma on Monday said the US health regulator has issued one observation after inspecting a plant owned by its US-based unit. The...
Possible carcinogens found in Mercks Sitagliptin drugs Januvia, Janumet: USFDA

Possible carcinogens found in Merck's Sitagliptin drugs Januvia, Janumet: USFDA

Ruchika Sharma10 Aug 2022 11:38 AM GMT
New Delhi: The U.S. Food and Drug Administration said on Tuesday certain samples of sitagliptin, a compound in Merck's diabetes drugs Januvia and...
Glenmark receives 6 USFDA observations for Baddi facility

Glenmark receives 6 USFDA observations for Baddi facility

Roshni Dhar24 Jun 2022 12:30 PM GMT
Drugmaker, Glenmark Pharmaceuticals Ltd, has recently announced that the US Food and Drug Administration (USFDA) has issued Form 483 with six...
Novel novel mesh plug effective for treatment of sidewall brain aneurysm

Novel novel mesh plug effective for treatment of sidewall brain aneurysm

Dr. Kamal Kant Kohli15 May 2022 4:00 PM GMT
OAK BROOK: A novel mesh plug that has been traditionally used to treat brain aneurysms occurring where the blood vessels branch out was found to be...
FDA approves mavacamten  for managing symptomatic obstructive hypertrophic cardiomyopathy

FDA approves mavacamten for managing symptomatic obstructive hypertrophic cardiomyopathy

Dr. Kamal Kant Kohli2 May 2022 5:00 AM GMT
The US Food and Drug Administration has approved mavacamten (Camzyos) for treatment of symptomatic obstructive hypertrophic cardiomyopathy...
Popolymer matrix-based sublingual epinephrine continues to show promise: EPIPHAST study

Popolymer matrix-based sublingual epinephrine continues to show promise: EPIPHAST study

Dr. Kamal Kant Kohli30 April 2022 3:30 AM GMT
Epinephrine can reach therapeutic plasma concentrations via sublingual administration confirm researchers during the second part of the ongoing...
USFDA issues 3 observations for Zydus Lifesciencess Vadodara plant

USFDA issues 3 observations for Zydus Lifesciences's Vadodara plant

MD Bureau11 March 2022 9:06 AM GMT
"We are confident of addressing and resolving the issues to the satisfaction of USFDA. We remain committed to building a quality culture across our...
FDA approves Empagliflozin  for heart failure despite contrary results

FDA approves Empagliflozin for heart failure despite contrary results

Dr. Nandita Mohan3 March 2022 1:15 PM GMT
Trials are being conducted to prevent cardiac death, The US Food and Drug Administration (FDA) has approved an expanded heart failure (HF) indication...
Semaglutide an effective alternative drug option to treat obesity

Semaglutide an effective alternative drug option to treat obesity

MD Editorial Team24 Feb 2022 3:30 AM GMT
Obesity is a seriously neglected disease that is factually a multifactorial chronic disease affecting 650 million adults globally. It is associated...
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