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Tag: usfda

You Searched For "usfda"
USFDA nod to Zydus Lifesciences Estradiol Transdermal System for postmenopausal osteoporosis prevention

USFDA nod to Zydus Lifesciences Estradiol Transdermal System for postmenopausal osteoporosis prevention

Ruchika Sharma19 April 2023 11:32 AM IST
The drug will be manufactured at the group's formulation manufacturing facility in Moraiya, Ahmedabad, India.
Caplin Steriles gets USFDA nod for Procainamide Hydrochloride Injection for treating abnormal heart rhythm

Zydus Lifesciences bags USFDA okay for Isoproterenol Hydrochloride Injection

Ruchika Sharma17 April 2023 11:29 AM IST
Ahmedabad: Drugmaker, Zydus Lifesciences Limited, has received final approval from the United States Food and Drug Administration (USFDA) to...
Novavax cut USD 50 million in costs, plans to slash more: CEO

Novavax cut USD 50 million in costs, plans to slash more: CEO

Ruchika Sharma15 April 2023 2:00 PM IST
United States: Novavax Inc cut about $50 million in costs in the first quarter of 2023 and plans to slash more, Chief Executive John Jacobs said in an...
USFDA approves Abbott Tendyne to replace mitral valve without open-heart surgery

USFDA clears reader for Abbott FreeStyle Libre 3 system

Ruchika Sharma15 April 2023 12:06 PM IST
The reader uses a rechargeable lithium-ion battery, which is commonly found in many other electronic devices like mobile phones.
USFDA pauses initiation of new patients on multiple sclerosis evobrutinib drug: Merck

USFDA pauses initiation of new patients on multiple sclerosis evobrutinib drug: Merck

Ruchika Sharma15 April 2023 11:19 AM IST
The company must now place on hold the initiation of new evobrutinib patients and halt studies involving patients who have been taking the drug for...
Eli Lilly Amyvid label update

Eli Lilly bowel disease drug Mirikizumab rejected by USFDA

Ruchika Sharma14 April 2023 3:00 PM IST
The health regulator cited issues related to the proposed manufacturing of the drug mirikizumab.
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

USFDA accepts application for Merck KEYTRUDA plus Chemotherapy as first line treatment for Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Ruchika Sharma14 April 2023 11:00 AM IST
KEYTRUDA is an anti-programmed death receptor-1 therapy that works by increasing the ability of the body's immune system to help detect and fight...
Takeda gets USFDA nod to expand use of HYQVIA to treat primary immunodeficiency in children

Takeda gets USFDA nod to expand use of HYQVIA to treat primary immunodeficiency in children

Ruchika Sharma14 April 2023 10:00 AM IST
Primary Immunodeficiency is an umbrella term to describe a group of more than 400 disorders that affect the body's immune system, increasing...
USFDA approves Zydus Lifesciences Tavaborole Topical Solution to treat fungal toenail infections

USFDA approves Zydus Lifesciences Tavaborole Topical Solution to treat fungal toenail infections

Ruchika Sharma12 April 2023 11:39 AM IST
The drug will be manufactured at the group's topical manufacturing facility at Changodar, Ahmedabad, India.
Shilpa Medicare Unit VI Bengaluru facility

Shilpa Medicare Psoriatic arthritis drug Apremilast gets USFDA okay

Ruchika Sharma11 April 2023 1:00 PM IST
Karnataka: Shilpa Medicare has recently announced that the Company has received final approval from the U.S Food and Drug...
Pfizer, Biogen among hundreds of US drugmakers calling for abortion pill Mifepristone ruling reversal

Pfizer, Biogen among hundreds of US drugmakers calling for abortion pill Mifepristone ruling reversal

Ruchika Sharma11 April 2023 12:15 PM IST
The FDA approved mifepristone, part of a two-drug regimen that accounts for more than half of US abortions, more than 20 years ago and has determined...
USFDA advisers to weigh full nod for Eisai-Biogen Alzheimers drug Leqembi

USFDA advisers to weigh full nod for Eisai-Biogen Alzheimer's drug Leqembi

Ruchika Sharma11 April 2023 10:00 AM IST
Leqembi belongs to a class of treatments that aim to slow the advance of the neurodegenerative disease by removing sticky clumps of the toxic protein...
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