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Results For "USFDA"

1248 News Found

Hyderabad startup’s Physiotherapy monitoring device ‘Pheezee’ receives USFDA
Medical Device | May 05, 2023

Hyderabad startup’s Physiotherapy monitoring device ‘Pheezee’ receives USFDA

Pheezee is designed to assess musculoskeletal and neuromuscular health.


USFDA puts on hold Sun Pharma trials on dermatological drug
Drug Approval | May 04, 2023

USFDA puts on hold Sun Pharma trials on dermatological drug

Sun Pharma said had a teleconference call with the US Food and Drug Administration (USFDA) regarding a pulmonary embolism (serious adverse events) occurring at the 12 mg dose


Laurus Labs receives USFDA tentative approval for Dolutegravir 5mg and 10mg in HIV/AIDS treatment
Drug Approval | May 03, 2023

Laurus Labs receives USFDA tentative approval for Dolutegravir 5mg and 10mg in HIV/AIDS treatment

It will help in bringing a significant benefit in compliance of ARV medication in the paediatric HIV treatment


USFDA Advisory Committee votes  n Lynparza plus Abiraterone and Prednisone  for prostate cancer
Drug Approval | May 03, 2023

USFDA Advisory Committee votes n Lynparza plus Abiraterone and Prednisone for prostate cancer

The committee voted that FDA should restrict use of LYNPARZA plus abi/pred to these BRCAm mCRPC patients


Zydus receives final approval from the USFDA for Metronidazole Topical Cream
Drug Approval | April 25, 2023

Zydus receives final approval from the USFDA for Metronidazole Topical Cream

Metronidazole is an antibiotic used on the skin to treat a certain skin disorder known as rosacea


USFDA suggests corrective measures to Sun Pharmaceutical’s Mohali facility
Drug Approval | April 24, 2023

USFDA suggests corrective measures to Sun Pharmaceutical’s Mohali facility

The USFDA had classified the inspection as "Official Action Indicated" (OAI).


Zydus receives final approval from the USFDA for Icosapent Ethyl Capsules
Drug Approval | April 24, 2023

Zydus receives final approval from the USFDA for Icosapent Ethyl Capsules

Icosapent Ethyl Capsules are indicated as an adjunct to diet to reduce triglyceride levels


USFDA lifts clinical hold on Phase 3 investigational new drug application for MaaT013
Drug Approval | April 24, 2023

USFDA lifts clinical hold on Phase 3 investigational new drug application for MaaT013

This is the first time the Agency has authorized the Phase 3 clinical evaluation in the U.S of a microbiota-based live biotherapeutic based on a pooling technology


Zydus receives final approval from the USFDA for Metoprolol Tartrate
Drug Approval | April 21, 2023

Zydus receives final approval from the USFDA for Metoprolol Tartrate

Metoprolol is used with or without other medications to treat high blood pressure (hypertension).


Zydus receives final approval from USFDA for Roflumilast Tablets, 250 mcg
Drug Approval | April 20, 2023

Zydus receives final approval from USFDA for Roflumilast Tablets, 250 mcg

Roflumilast reduces inflammation in the lungs that leads to chronic obstructive pulmonary disease (COPD)