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Results For "European-Union"

187 News Found

Tagrisso recommended for approval in the EU for unresectable EGFR-mutated lung cancer
Drug Approval | November 19, 2024

Tagrisso recommended for approval in the EU for unresectable EGFR-mutated lung cancer

Recommendation based on LAURA Phase III trial results which showed Tagrisso extended median progression-free survival to more than three years


Blenrep shows overall survival benefit in DREAMM-7 phase III trial for relapsed/refractory multiple myeloma
Diagnostic Center | November 19, 2024

Blenrep shows overall survival benefit in DREAMM-7 phase III trial for relapsed/refractory multiple myeloma

Statistically significant and clinically meaningful reduction in the risk of death seen with Blenrep (belantamab mafodotin) plus bortezomib and dexamethasone (BorDex) versus daratumumab plus BorDex


Merck receives positive EU CHMP opinion for pembrolizumab plus chemotherapy as first-line treatment for unresectable non-epithelioid MPM
Drug Approval | November 16, 2024

Merck receives positive EU CHMP opinion for pembrolizumab plus chemotherapy as first-line treatment for unresectable non-epithelioid MPM

Opinion granted based on positive overall survival results from the IND.227/KEYNOTE-483 trial


Venus Remedies gets approval from Malaysian PIC/S GMP for pre-filled syringe facility
News | November 06, 2024

Venus Remedies gets approval from Malaysian PIC/S GMP for pre-filled syringe facility

The recognition from Malaysia's NPRA, a member of PIC/S, opens doors to new global business opportunities


European Food Safety Authority confirms safety of silica as food additive
News | October 23, 2024

European Food Safety Authority confirms safety of silica as food additive

Silica is a proven and highly effective anti-caking agent that has been used for decades


Natac receives GMP certificate to manufacture for the pharmaceutical sector
News | October 12, 2024

Natac receives GMP certificate to manufacture for the pharmaceutical sector

The GMP certificate will allow the manufacturing site in Hervás, Cáceres to manufacture active ingredients for the pharmaceutical industry that is based on medicinal plants


SMS Pharma receives EDQM certification to supply Ibuprofen in Europe
Drug Approval | October 02, 2024

SMS Pharma receives EDQM certification to supply Ibuprofen in Europe

The inspection conducted by EDQM at its Visakhapatnam facility


Pfizer and BioNTech receive positive CHMP opinion for Omicron KP.2-adapted COVID-19
News | September 23, 2024

Pfizer and BioNTech receive positive CHMP opinion for Omicron KP.2-adapted COVID-19

Doses will be ready to ship to applicable European Union (EU) member states as soon as possible upon European Commission (EC) authorization


Fermenta Biotech receives EU GMP Certification for its Dahej facility
News | September 23, 2024

Fermenta Biotech receives EU GMP Certification for its Dahej facility

This approval reflects company’s unwavering commitment that the quality assurance