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Results For "U.S.-Food-and-Drug-Administration"

489 News Found

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


Merck completes acquisition of Harpoon Therapeutics
News | March 12, 2024

Merck completes acquisition of Harpoon Therapeutics

Acquisition broadens oncology pipeline with a portfolio of novel T-cell engagers including HPN328 (MK-6070), an investigational delta-like ligand 3 (DLL3) targeting T-cell engager


USFDA grants orphan drug and pediatric exclusivities for Cresemba for aspergillosis and mucormycosis in children
Drug Approval | March 12, 2024

USFDA grants orphan drug and pediatric exclusivities for Cresemba for aspergillosis and mucormycosis in children

CRESEMBA receives seven years and six months of US market exclusivity for these pediatric indications


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


Bayer strengthens pharma portfolio with new cardiology drug acoramidis
News | March 06, 2024

Bayer strengthens pharma portfolio with new cardiology drug acoramidis

Acquisition of exclusive commercialization rights for European markets


New England Journal of Medicine publishes Phase III data showing Xolair significantly reduced allergic reactions with food allergies
Diagnostic Center | February 28, 2024

New England Journal of Medicine publishes Phase III data showing Xolair significantly reduced allergic reactions with food allergies

The U.S. FDA recently approved Xolair as the first and only medicine for children and adults with one or more food allergies


Glenmark partners Pfizer to launch Abrocitinib in India
Drug Approval | February 01, 2024

Glenmark partners Pfizer to launch Abrocitinib in India

Developed by Pfizer, Abrocitinib has received marketing authorization from the Central Drugs Standard Control Organization (CDSCO) in India


Bayer, Sun Pharma sign marketing and distribution agreement for second brand of Finerenone in India
News | January 17, 2024

Bayer, Sun Pharma sign marketing and distribution agreement for second brand of Finerenone in India

Bayer has granted the non-exclusive rights to Sun Pharma to market and distribute a second brand of Finerenone under the brand name Lyvelsa


USFDA approves Merck’s Keytruda plus chemoradiotherapy with FIGO 2014 stage III-IVA cervical cancer
Drug Approval | January 13, 2024

USFDA approves Merck’s Keytruda plus chemoradiotherapy with FIGO 2014 stage III-IVA cervical cancer

Keytruda is the first and only anti-PD-1 therapy approved in combination with chemoradiotherapy for these patients


USFDA accepts sBLA of TIVDAK for priority review for patients with metastatic cervical cancer
Drug Approval | January 10, 2024

USFDA accepts sBLA of TIVDAK for priority review for patients with metastatic cervical cancer

Submission based on positive results from global phase 3 study demonstrating overall survival benefit of TIVDAK over chemotherapy