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1676 News Found

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


Ajinomoto Bio-Pharma receives FDA approval for high potency fill line
Drug Approval | April 22, 2023

Ajinomoto Bio-Pharma receives FDA approval for high potency fill line

Aji Bio-Pharma has six fill finish lines located in San Diego, including a new line


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)


Jubilant Ingrevia commissions acetic anhydride plant at Bharuch
News | April 20, 2023

Jubilant Ingrevia commissions acetic anhydride plant at Bharuch

This plant adds around 60,000 MT of capacity, scaling Jubilant Ingrevia Limited’s overall annual Acetic Anhydride capacity to 210,000 MT


Zydus receives final approval from the USFDA for Estradiol Transdermal System
Drug Approval | April 19, 2023

Zydus receives final approval from the USFDA for Estradiol Transdermal System

Estradiol Transdermal System USP, 0.014 mg/day (weekly) had annual sales of USD 1.9 mn in the United States


Zydus receives final approval from the USFDA for Isoproterenol Hydrochloride Injection
Drug Approval | April 17, 2023

Zydus receives final approval from the USFDA for Isoproterenol Hydrochloride Injection

Isoproterenol hydrochloride injection is indicated to improve hemodynamic status in patients in distributive shock and shock due to reduced cardiac output


Moderna and Merck announce an investigational individualized neoantigen therapy
Clinical Trials | April 17, 2023

Moderna and Merck announce an investigational individualized neoantigen therapy

mRNA-4157 (V940) in combination with KEYTRUDA reduced the risk of recurrence or death by 44% compared to KEYTRUDA alone in stage III/IV melanoma patients


NS Pharma announces FDA clearance to initiate phase II study for an Exon 44 skipping candidate
Drug Approval | April 15, 2023

NS Pharma announces FDA clearance to initiate phase II study for an Exon 44 skipping candidate

Study efficacy measures will include the expression of dystrophin protein and motor function.