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Results For "U.S.-FDA"

291 News Found

Zydus Cadila receives U.S.FDA approval for leukaemia injection
Drug Approval | November 18, 2021

Zydus Cadila receives U.S.FDA approval for leukaemia injection

Nelarabine is in a class of medications called antimetabolites


IVD system to assist assay developers and clinical labs for molecular diagnostics
Medical Device | November 10, 2021

IVD system to assist assay developers and clinical labs for molecular diagnostics

Thermo Fisher Scientific expands diagnostics portfolio to support full qPCR assay development and testing workflow


Pfizer’s Covid-19 drug a potential game changer
Biotech | November 08, 2021

Pfizer’s Covid-19 drug a potential game changer

In the overall study population through Day 28, no deaths were reported in patients who received Paxlovid as compared to 10 deaths in patients who received placebo


Prime Therapeutics to list Semglee and Insulin Glargine
News | November 05, 2021

Prime Therapeutics to list Semglee and Insulin Glargine

Biocon Biologics and Viatris co-developed the products


Sun Pharma's Winlevi available in the US
Drug Approval | November 01, 2021

Sun Pharma's Winlevi available in the US

It is the first U.S. FDA approved novel topical mechanism for acne in nearly 40 years


Biocon reports a consolidated net profit of Rs. 138.3 crore in Q2FY22
News | October 25, 2021

Biocon reports a consolidated net profit of Rs. 138.3 crore in Q2FY22

The Research Services and Biosimilars business segments reported a growth of 17% and 10%, respectively


Zydus announces update on a randomised trial of Saroglitazar Mg in NASH
Biotech | October 22, 2021

Zydus announces update on a randomised trial of Saroglitazar Mg in NASH

Incidences of Non-alcoholic Fatty Liver Disease (NAFLD) have been rising exponentially worldwide and are associated with co-morbidities including obesity, diabetes, hypertension and metabolic disorders


Sage Therapeutics and Biogen plan to submit a New Drug Application (NDA) for zuranolone
Biotech | October 21, 2021

Sage Therapeutics and Biogen plan to submit a New Drug Application (NDA) for zuranolone

Following the pre-NDA meeting with the U.S. FDA, the companies confirmed the current efficacy and safety databases are expected to be adequate for filing with confirmed pathways for MDD and PPD


Biocon Biologics’ interchangeable biosimilar insulin Glargine preferred on Express Scripts
News | October 21, 2021

Biocon Biologics’ interchangeable biosimilar insulin Glargine preferred on Express Scripts

Express Scripts, a leading pharmacy benefit management organization, will list Viatris labelled biosimilar insulin Glargine as a preferred insulin brand on its National Preferred Formulary (NPF)


Granules gets ANDA approval for Dofetilide capsules
Drug Approval | October 18, 2021

Granules gets ANDA approval for Dofetilide capsules

The capsules are indicated for the maintenance of normal sinus rhythm in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm