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Tag: usfda

You Searched For "usfda"
GSK Shingrix new prefilled syringe

GSK to withdraw blood cancer drug Blenrep from US market

Ruchika Sharma22 Nov 2022 4:15 PM IST
GSK said access to Blenrep in other countries where it is marketed is unaffected, including across the European Union.
Glenmarks Telma Surpasses Rs 1,000 Crore Revenue, Recognized in Harvard Case Study

Glenmark Pharma settles with Pfizer for Axitinib Tablets

Ruchika Sharma22 Nov 2022 2:30 PM IST
Mumbai: Glenmark Pharmaceuticals Inc., USA (Glenmark) and Glenmark Pharmaceuticals Limited have reached a settlement agreement with Pfizer ...
Alembic Pharma bags USFDA nod for Hypertension drug Nifedipine Extended Release

Alembic Pharma bags USFDA nod for Hypertension drug Nifedipine Extended Release

Ruchika Sharma21 Nov 2022 2:30 PM IST
Nifedipine Extended-Release Tablets are indicated for the management of i) Vasospastic Angina ii) Chronic Stable Angina (Classical EffortAssociated...
Philips flags new problems with previously-replaced ventilators

Philips flags new problems with previously-replaced ventilators

Ruchika Sharma21 Nov 2022 9:00 AM IST
The FDA said the company had notified it that the sound abatement foam could come loose in some refurbished models, "lowering the inspiratory...
Zefylti

Aurobindo Pharma Sangareddy facility gets 10 USFDA observations

Ruchika Sharma20 Nov 2022 3:30 PM IST
Hyderabad: Drugmaker Aurobindo Pharma has recently announced that the United States Food and Drug Administration (USFDA) has concluded an inspection...
Roche bags USFDA nod for companion diagnostic to identify patients with HER2-ultralow metastatic breast cancer eligible for Enhertu

Roche gets USFDA nod for VENTANA FOLR1 RxDx Assay to detect ovarian cancer patients eligible for ELAHERE

Ruchika Sharma19 Nov 2022 1:30 PM IST
Ovarian cancer is the eighth most common cancer in women worldwide and patients often have advanced disease when diagnosed.
Tzield, the Worlds First USFDA approved drug to delay type 1 diabetes onset to cost more than Rs 11 lakh per vial, confirm makers

Tzield, the World's First USFDA approved drug to delay type 1 diabetes onset to cost more than Rs 11 lakh per vial, confirm makers

Ruchika Sharma19 Nov 2022 11:49 AM IST
New Jersey: With the recent USFDA, approval of the first drug to delay type 1 diabetes onset, teplizumab, makers of the drug Provention Bio...
Ardelyx Kidney disease drug Tenapanor backed by USFDA advisers

Ardelyx Kidney disease drug Tenapanor backed by USFDA advisers

Ruchika Sharma19 Nov 2022 11:00 AM IST
Los Angels: A panel of advisers to the U.S. health regulator on Wednesday recommended the approval of Ardelyx Inc's drug for chronic kidney disease...
Caplin Steriles gets USFDA nod for Procainamide Hydrochloride Injection for treating abnormal heart rhythm

Strides Pharma Science Singapore arm secures USFDA okay for Potassium Chloride Oral Solution

Ruchika Sharma18 Nov 2022 3:30 PM IST
Potassium Chloride Oral Solution is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for...
Zefylti

Aurobindo Pharma subsidiary bags USFDA nod for Amphotericin B Liposome for Injection

Ruchika Sharma18 Nov 2022 2:30 PM IST
This is a partnership product from TTY Biopharm Company Limited and will be manufactured at their Taiwan facility and marketed by Eugia Pharma.
Natco Pharma gets 7 USFDA observations for Kothur Pharma Division

USFDA successfully completes inspection at Bajaj Healthcare Vadodara facility

Ruchika Sharma18 Nov 2022 1:15 PM IST
Thane: Bajaj Healthcare Limited (BHL), a manufacturer of APIs, Intermediates, and Formulations, has announced a successful competition of the...
Sun Pharma, Philogen complete patient enrollment in Phase III trial for Soft Tissue Sarcoma

Sun Pharma gets USFDA nod for neonatal seizures treatment SEZABY

Ruchika Sharma18 Nov 2022 12:15 PM IST
SEZABY is a benzyl alcohol-free and propylene glycol-free formulation of phenobarbital sodium powder for injection.
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