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Results For "European-Medicines-Agency"

207 News Found

Lupin completes  successful Phase 3 trials for Lucentis biosimilar
Biotech | August 06, 2024

Lupin completes successful Phase 3 trials for Lucentis biosimilar

The successful completion of the global Phase 3 trials paves the way to obtain marketing approval in the U.S. and EU


Dr. Reddy's receives positive CHMP opinion from EMA for its proposed Rituximab biosimilar
Drug Approval | July 30, 2024

Dr. Reddy's receives positive CHMP opinion from EMA for its proposed Rituximab biosimilar

Dr. Reddy's had previously received the EU GMP certificate for its Rituximab drug substance


European Commission approves Pfizer’s Durveqtix gene therapy for adults with hemophilia B
Drug Approval | July 26, 2024

European Commission approves Pfizer’s Durveqtix gene therapy for adults with hemophilia B

A one-time dose of DURVEQTIX has reduced bleeds post-treatment compared to standard of care with a median annualized bleed rate (ABR) of zero bleeds (range 0 to 9.9)


Ligand to acquire Apeiron Biologics for US$100 million
News | July 09, 2024

Ligand to acquire Apeiron Biologics for US$100 million

Acquisition provides Ligand with the royalty rights to QARZIBA, a highly differentiated, commercial oncology drug marketed in 35 countries by global pharmaceutical company Recordati S.p.A.


Sipavibart EMA regulatory submission accepted under accelerated assessment for COVID-19 prevention
Drug Approval | July 03, 2024

Sipavibart EMA regulatory submission accepted under accelerated assessment for COVID-19 prevention

Submission based on positive SUPERNOVA Phase III trial data which demonstrated a statistically significant reduction in the incidence of COVID?19 in an immunocompromised patient population


Lynparza and Imfinzi combination recommended for approval in the EU by CHMP for recurrent endometrial cancer
Drug Approval | July 02, 2024

Lynparza and Imfinzi combination recommended for approval in the EU by CHMP for recurrent endometrial cancer

Imfinzi also recommended for patients with mismatch repair deficient disease


Pfizer and BioNTech receive Positive CHMP opinion for Omicron JN.1-adapted COVID-19 vaccine in EU
News | June 28, 2024

Pfizer and BioNTech receive Positive CHMP opinion for Omicron JN.1-adapted COVID-19 vaccine in EU

Doses will be ready to ship to applicable EU member states immediately upon authorization by the European Commission


EMA approves Biocon Biologics’ new mAbs facility in India
News | June 24, 2024

EMA approves Biocon Biologics’ new mAbs facility in India

Renews GMP certifications for India and Malaysia sites


AstraZeneca’s Tagrisso plus chemo recommended for approval in EU
Drug Approval | June 05, 2024

AstraZeneca’s Tagrisso plus chemo recommended for approval in EU

Recommendation based on FLAURA2 results which showed Tagrisso plus chemotherapy extended median progression-free survival by nearly 9 months


AbbVie receives positive CHMP opinion for Risankizumab for treatment ulcerative colitis
News | June 01, 2024

AbbVie receives positive CHMP opinion for Risankizumab for treatment ulcerative colitis

Ulcerative Colitis (UC) is a chronic, idiopathic, immune-mediated inflammatory bowel disease (IBD) affecting the large intestine