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Results For "Food-and-Drug-Administration"

1017 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


USFDA grants Orphan Drug Designation for iOnctura's first-in-class autotaxin cancer therapy
Biotech | March 12, 2024

USFDA grants Orphan Drug Designation for iOnctura's first-in-class autotaxin cancer therapy

It is the first autotaxin inhibitor to be investigated in cancer patients


USFDA conducts inspection at Alembic Pharmaceuticals' Panelav oncology formulation facility
Drug Approval | March 09, 2024

USFDA conducts inspection at Alembic Pharmaceuticals' Panelav oncology formulation facility

The company will provide comprehensive response to USFDA for the observations


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


Cipla incorporates JV company in USA
News | March 02, 2024

Cipla incorporates JV company in USA

Cipla completes transfer of Generics Business Undertaking


Briefs: Eugia Pharma Specialities and Eugia SEZ
News | March 01, 2024

Briefs: Eugia Pharma Specialities and Eugia SEZ

Eugia Pharma Specialities restarts production at terminally sterilized product lines


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