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Results For "European-Union"

203 News Found

Imfinzi plus Imjudo recommended for approval in the EU by CHMP for advanced liver and lung cancers
Drug Approval | December 20, 2022

Imfinzi plus Imjudo recommended for approval in the EU by CHMP for advanced liver and lung cancers

Positive opinions based on significant survival benefit


Takeda’s dengue vaccine QDENGA approved for use in EU
Drug Approval | December 09, 2022

Takeda’s dengue vaccine QDENGA approved for use in EU

The approval follows the positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in October 2022


Pfizer and BioNTech report new data on Omicron BA.4/BA.5-adapted bivalent booster
Diagnostic Center | November 21, 2022

Pfizer and BioNTech report new data on Omicron BA.4/BA.5-adapted bivalent booster

Omicron BA.5 continues to be the most prevalent sublineage in the United States (nearly 30% of cases) at the time of publication of the data


IOL Chemicals and Pharmaceuticals Q2FY23 net profit drops to Rs 15.6 Cr
News | November 15, 2022

IOL Chemicals and Pharmaceuticals Q2FY23 net profit drops to Rs 15.6 Cr

The company registered with REACH Certificate for Ethyl Acetate with a tonnage band of more than 1000 TPA


Lynparza in combination with Abiraterone and prednisone receives positive opinion from EU CHMP
Drug Approval | November 15, 2022

Lynparza in combination with Abiraterone and prednisone receives positive opinion from EU CHMP

First PARP inhibitor to demonstrate clinical benefit in radiographic progression-free survival in combination with a new hormonal agent with or without homologous recombination repair gene mutations


Pfizer and BioNTech receive positive CHMP opinion for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster
Drug Approval | November 11, 2022

Pfizer and BioNTech receive positive CHMP opinion for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster

The European Commission will review the CHMP recommendation and is expected to make a final decision soon.


Pfizer and BioNTech submit application to USFDA for emergency use authorization of Omicron BA.4/BA.5-adapted bivalent vaccine booster for 5-11 year age
Drug Approval | September 27, 2022

Pfizer and BioNTech submit application to USFDA for emergency use authorization of Omicron BA.4/BA.5-adapted bivalent vaccine booster for 5-11 year age

The companies have also initiated a Phase 1/2/3 study NCT05543616 to evaluate the safety, tolerability, and immunogenicity of different doses


Lynparza approved in China as first-line maintenance treatment with Bevacizumab for HRD- positive advanced ovarian cancer
Drug Approval | September 23, 2022

Lynparza approved in China as first-line maintenance treatment with Bevacizumab for HRD- positive advanced ovarian cancer

One in two women with advanced ovarian cancer has an HRD-positive tumor


Charsire's new drug aims to capture dementia treatment market
Biotech | September 22, 2022

Charsire's new drug aims to capture dementia treatment market

Charsire Biotechnology Corp. has successfully developed a revolutionary new drug (BAC) for Alzheimer's disease


BridgeBio Pharma, Sentynl Therapeutics receive marketing authorization in the EU for fosdenopterin
Drug Approval | September 22, 2022

BridgeBio Pharma, Sentynl Therapeutics receive marketing authorization in the EU for fosdenopterin

NULIBRY is a first-in-class cPMP substrate replacement therapy to reduce the risk of mortality in patients with MoCD Type A.