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Tag: usfda

You Searched For "usfda"
Sanofi Sarclisa approved in EU

Sanofi Dupixent sBLA for treatment of eosinophilic esophagitis in children aged 1 to 11 accepted for USFDA priority review

Ruchika Sharma28 Sept 2023 2:30 PM IST
Paris: Sanofi has announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License...
Cough syrup deaths overseas prompts US crackdown on toxic testing

Cough syrup deaths overseas prompts US crackdown on toxic testing

Ruchika Sharma27 Sept 2023 3:30 PM IST
The U.S. FDA is cracking down on lax testing practices by dozens of makers of healthcare products following hundreds of deaths overseas from...
High level delegation from USFDA visits Divis Labs Choutuppal facility

High level delegation from USFDA visits Divi's Labs Choutuppal facility

Ruchika Sharma27 Sept 2023 11:37 AM IST
Hyderabad: Divi's Laboratories Limited has announced that a high-level delegation from the U.S. Food and Drug Administration (USFDA), including...
Gland Pharma reports nearly 50% jump in Q1 profit

Gland Pharma gets USFDA EIR for Pashamylaram Facility

Ruchika Sharma26 Sept 2023 3:30 PM IST
Hyderabad: Gland Pharma has announced that the Company has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration...
Strides Pharma Science Singapore arm gets USFDA nod for Icosapent Ethyl Capsules to reduce heart issues

Strides Pharma Science Singapore arm gets USFDA nod for Icosapent Ethyl Capsules to reduce heart issues

Ruchika Sharma25 Sept 2023 11:21 AM IST
Icosapent Ethyl Capsule is a prescription medication used in conjunction with other medicines like statins to reduce the risk of heart attack, stroke...
Eli Lilly Amyvid label update

Eli Lilly-Boehringer Ingelheim Jardiance gets USFDA approval for adults with chronic kidney disease

Ruchika Sharma23 Sept 2023 12:30 PM IST
Ridgefield: Eli Lilly and Company and Boehringer Ingelheim have announced that the U.S. Food and Drug Administration (FDA) has approved Jardiance...
Merck gets USFDA Priority Review for application for Keytruda plus standard of care as Perioperative treatment for Resectable Locally Advanced Head, Neck Squamous Cell Carcinoma

Merck gets USFDA priority review for Keytruda plus concurrent chemoradiotherapy for cervical cancer

Ruchika Sharma21 Sept 2023 5:33 PM IST
Rahway: Merck, known as MSD outside of the United States and Canada, has announced the U.S. Food and Drug Administration (FDA) has accepted for...
Merck Welireg get USFDA priority review for certain previously treated patients with Advanced Renal Cell Carcinoma

Merck Welireg get USFDA priority review for certain previously treated patients with Advanced Renal Cell Carcinoma

Ruchika Sharma21 Sept 2023 2:48 PM IST
Rahway: Merck, known as MSD outside of the United States and Canada, has announced the U.S. Food and Drug Administration (FDA) has accepted and...
USFDA issues 5 observations to Cipla US arm

USFDA issues 5 observations to Cipla US arm

Ruchika Sharma21 Sept 2023 12:30 PM IST
Mumbai: Cipla has recently announced that the United States Food and Drug Administration (USFDA) has concluded the inspection with five...
Zydus bags USFDA nod for acne gel Clindamycin Phosphate

Zydus bags USFDA nod for acne gel Clindamycin Phosphate

Ruchika Sharma21 Sept 2023 11:30 AM IST
The drug will be manufactured at the group's topical manufacturing facility at Changodar, Ahmedabad, India.
Medical Bulletin 20/September/2023

Medical Bulletin 20/September/2023

Isra Zaman20 Sept 2023 3:15 PM IST
Here are the top medical news of the day:Combination of job strain, high efforts, and low rewards doubled the risk of heart disease in menMen who say...
Low BP treatment: Caplin Steriles bags USFDA nod for Norepinephrine Bitartrate Injection

Low BP treatment: Caplin Steriles bags USFDA nod for Norepinephrine Bitartrate Injection

Ruchika Sharma20 Sept 2023 1:30 PM IST
Chennai: Caplin Steriles Limited, a Subsidiary Company of Caplin Point Laboratories Limited, has been granted final approval by the United States...
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