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Tag: usfda

You Searched For "usfda"
Abbott bags USFDA nod for TactiFlex Ablation Catheter to treat abnormal heart rhythm

Abbott bags USFDA nod for TactiFlex Ablation Catheter to treat abnormal heart rhythm

Ruchika Sharma24 May 2023 1:30 PM IST
TactiFlex catheter uses a tip design with a laser-cut pattern that flexes when in contact with the heart wall.
Wockhardt Zaynich successfully treats paediatric cancer patient with recalcitrant blood, liver infection

Wockhardt, its directors settle insider trading case with Sebi in Rs 76.68 lakh

Ruchika Sharma23 May 2023 11:40 AM IST
It was alleged that they had violated the Securities Contracts (Regulation) Act (SCRA) and insider trading rules.
Shilpa Medicare Unit VI Bengaluru facility

Shilpa Medicare gets USFDA VAI status for Hyderabad unit

Ruchika Sharma22 May 2023 2:43 PM IST
Karnataka: Shilpa Medicare has announced that the US FDA GMP inspection performed on Company’s Analytical Services Division situated on first...
USFDA successfully concludes inspection at Piramal Pharma Pithampur facility

USFDA successfully concludes inspection at Piramal Pharma Pithampur facility

Ruchika Sharma22 May 2023 12:43 PM IST
Mumbai: Piramal Pharma Limited has announced that the US Food and Drug Administration (USFDA) has successfully concluded an inspection at the...
Biocon Biologics expands biosimilar insulin portfolio with USFDA nod of Kirsty

Biocon gets zero UFSDA observations for Hyderabad facility

Ruchika Sharma22 May 2023 12:12 PM IST
Bangalore: Biocon has announced that the US Food and Drug Administration (USFDA) has completed a pre-approval inspection at the...
Thermo Fisher Scientific bags USFDA clearance for Preeclampsia risk assessment assays

Thermo Fisher Scientific bags USFDA clearance for Preeclampsia risk assessment assays

Ruchika Sharma21 May 2023 12:45 PM IST
Waltham: Thermo Fisher Scientific Inc. has announced that the U.S. Food and Drug Administration (FDA) has cleared the Thermo Scientific...
Abbott gets USFDA nod for spinal cord stimulation devices for chronic back pain in people who have limited surgical options

Abbott gets USFDA nod for spinal cord stimulation devices for chronic back pain in people who have limited surgical options

Ruchika Sharma21 May 2023 11:00 AM IST
Abbott Park, Ill.: Abbott has announced that the U.S. Food and Drug Administration (FDA) has approved its spinal cord stimulation (SCS) devices...
Aurobindo Pharma restarts production at Kakinada Penicillin-G plant after fire incident

Aurobindo Pharma Anakapalli facility gets 4 USFDA observations

Ruchika Sharma20 May 2023 12:31 PM IST
Hyderabad: Aurobindo Pharma has announced that the company has received four observations from the United States Food and Drug Administration (US FDA)...
AbbVie gets USFDA nod for EPKINLY to treat adult patients with relapsed or refractory Diffuse Large B-Cell Lymphoma

AbbVie gets USFDA nod for EPKINLY to treat adult patients with relapsed or refractory Diffuse Large B-Cell Lymphoma

Ruchika Sharma20 May 2023 11:30 AM IST
DLBCL is a type of aggressive, fast-growing non-Hodgkin's lymphoma, a cancer that develops in the lymphatic system and affects B cells, a type of...
Pfizer Told To Conduct Phase IV Trial of Abrocitinib in Indian Adolescents with Atopic Dermatitis

USFDA panel votes in support of Pfizer RSV maternal vaccine

Ruchika Sharma19 May 2023 3:57 PM IST
New York: Pfizer Inc. has announced that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory...
Strides Pharma Science Acetaminophen and Ibuprofen Tablets

Strides Pharma Science gets USFDA EIR for Puducherry facility

Ruchika Sharma19 May 2023 12:24 PM IST
Bengaluru: Strides Pharma Science Limited has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA)...
Granules India bags USFDA nod for Venlafaxine Hydrochloride ER Capsules

Granules India bags USFDA nod for Venlafaxine Hydrochloride ER Capsules

Ruchika Sharma19 May 2023 11:30 AM IST
Venlafaxine HCl extended-release capsules are indicated for the treatment of Major Depressive Disorder, Generalized Anxiety Disorder, Social Anxiety...
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