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Results For "European-Medicines-Agency"

257 News Found

Dr. Reddy's launches Toripalimab in India
News | December 01, 2024

Dr. Reddy's launches Toripalimab in India

The first and only immuno-oncology drug approved for the treatment of nasopharyngeal carcinoma


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


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


EMA grants GMP Certificate of compliance to CuraTeQ biosimilars’ Hyderabad facility
Drug Approval | November 13, 2024

EMA grants GMP Certificate of compliance to CuraTeQ biosimilars’ Hyderabad facility

The GMP inspection assessed mammalian and microbial drug substance manufacturing facility sections


Sanofi’s dupixent approved in the US as the first-ever biologic medicine for patients with COPD
Drug Approval | September 27, 2024

Sanofi’s dupixent approved in the US as the first-ever biologic medicine for patients with COPD

Dupixent is indicated for the approximately 300,000 adults in the US with inadequately controlled COPD and an eosinophilic phenotype


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


Merck receives positive EU CHMP opinions for pembrolizumab regimens for gynecologic cancers
Clinical Trials | September 20, 2024

Merck receives positive EU CHMP opinions for pembrolizumab regimens for gynecologic cancers

Positive opinion granted for KEYTRUDA plus chemotherapy for the first-line treatment of adult patients with primary advanced or recurrent endometrial carcinoma


Merck announces Phase 3 trial initiation for Bomedemstat
Clinical Trials | August 27, 2024

Merck announces Phase 3 trial initiation for Bomedemstat

The initiation of a second Phase 3 clinical trial for bomedemstat demonstrates company’s commitment to advancing research in myeloproliferative neoplasms (MPNs)


EMA validates Bristol Myers Squibb’s application for CAR T cell therapy Breyanzi for relapsed or refractory follicular lymphoma
News | August 19, 2024

EMA validates Bristol Myers Squibb’s application for CAR T cell therapy Breyanzi for relapsed or refractory follicular lymphoma

Application based on the Transcend FL trial in which Breyanzi showed deep and durable responses and a consistent and well-established safety profile


Biocon posts Q1 FY25 PAT higher at Rs. 660 Cr
News | August 10, 2024

Biocon posts Q1 FY25 PAT higher at Rs. 660 Cr

This strong performance was primarily on account of a one-time gain from the strategic collaboration between Biocon Biologics and Eris Lifesciences.