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Results For "FDA"

2061 News Found

Biocon to obtain approval for diabetes drug, Liraglutide in UK
Drug Approval | March 28, 2024

Biocon to obtain approval for diabetes drug, Liraglutide in UK

Liraglutide is a drug-device combination formulation used in the treatment of Type 2 Diabetes Mellitus


Caplin Group commences operations of Rs. 150 crore oncology facility
News | March 28, 2024

Caplin Group commences operations of Rs. 150 crore oncology facility

The facility will manufacture tablets, capsules, and injections for the oncology segment


Ultomiris approved in the US for the treatment of adults with neuromyelitis optica spectrum disorder
Drug Approval | March 27, 2024

Ultomiris approved in the US for the treatment of adults with neuromyelitis optica spectrum disorder

First and only long-acting C5 complement inhibitor offers patients with AQP4 Ab+


Briefs: Concord Biotech and Neuland Laboratories
Drug Approval | March 23, 2024

Briefs: Concord Biotech and Neuland Laboratories

The inspection at Unit 1 by the USFDA has been successfully completed, with no observations under Form 483


AstraZeneca’s FLAURA2 Phase III trial showed favourable trend in EGFR-mutated advanced lung cancer
Clinical Trials | March 23, 2024

AstraZeneca’s FLAURA2 Phase III trial showed favourable trend in EGFR-mutated advanced lung cancer

Combination shows consistent benefit across prespecified post-progression outcomes


Grace expands CDMO capacity by 25% of South Haven facility in Michigan
News | March 19, 2024

Grace expands CDMO capacity by 25% of South Haven facility in Michigan

Additional capacity broadens Grace’s fine chemical capabilities for API production


Syngene biologics facility to be operational for US, European customers from mid-year
News | March 17, 2024

Syngene biologics facility to be operational for US, European customers from mid-year

New facility includes 20KL of single use drug substance capacity coupled with drug product filling capacity of up to one million vials per day


European Commission approves Pfizer’s Prevenar 20 to help protect infants and children against pneumococcal disease
Drug Approval | March 13, 2024

European Commission approves Pfizer’s Prevenar 20 to help protect infants and children against pneumococcal disease

PREVENAR offers the broadest serotype coverage of any pediatric pneumococcal conjugate vaccine to help protect infants and children from the 20 serotypes responsible for the majority of currently circulating pneumococcal disease in the EU and globally


Pfizer announces positive Phase 3 trial of ADCETRIS regimen in patients with DLBCL
Clinical Trials | March 12, 2024

Pfizer announces positive Phase 3 trial of ADCETRIS regimen in patients with DLBCL

Pfizer to discuss regulatory submission with FDA, potentially leading to eighth indication for ADCETRIS