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Results For "European-Union"

229 News Found

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)


Rusan Pharma’s API plant in Ankleshwar receives USFDA GMP approval
Drug Approval | July 22, 2024

Rusan Pharma’s API plant in Ankleshwar receives USFDA GMP approval

Rusan’s API facility in Ankleshwar is GMP approved by other stringent international agencies as well


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


Truqap plus Faslodex approved in the EU for patients with advanced ER-positive breast cancer
News | June 22, 2024

Truqap plus Faslodex approved in the EU for patients with advanced ER-positive breast cancer

Approval based on CAPItello-291 results which showed this combination reduced the risk of disease progression or death by 50% vs. Faslodex alone in a biomarker-altered population


Sun Pharma and Moebius Medical present Phase 2b study on MM-II
Clinical Trials | June 15, 2024

Sun Pharma and Moebius Medical present Phase 2b study on MM-II

There is an urgent need for more therapeutic treatment options for patients with painful osteoarthritis


Abbott wins CE mark for dual-chamber leadless pacemaker
News | June 11, 2024

Abbott wins CE mark for dual-chamber leadless pacemaker

Abbott's first-of-its-kind i2i technology enables synchronized communication between two leadless pacemakers


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


Zydus announces completion of Enrolment for Phase II clinical trial of Usnoflast
Clinical Trials | May 25, 2024

Zydus announces completion of Enrolment for Phase II clinical trial of Usnoflast

ALS is a rare, progressive and fatal neurodegenerative disease, with an average life expectancy of 3 to 5 years from the time of symptom onset