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Results For "European-Medicines-Agency"

172 News Found

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


Merck announces positive data for investigational, 21-Valent pneumococcal conjugate vaccine
Diagnostic Center | May 02, 2024

Merck announces positive data for investigational, 21-Valent pneumococcal conjugate vaccine

Late-breaker Phase 3 STRIDE-10 trial presented as an oral presentation at European Society of Clinical Microbiology and Infectious Diseases


AstraZeneca’s Truqap plus Faslodex recommended for approval in the EU by CHMP for cancer treatment
Drug Approval | April 29, 2024

AstraZeneca’s Truqap plus Faslodex recommended for approval in the EU by CHMP for cancer treatment

Recommendation based on CAPItello-291 results which showed the Truqap combination reduced the risk of disease progression or death by 50%


CHMP adopts positive opinion recommending approval of Bristol Myers Squibb’s Opdivo in combination with Cisplatin and Gemcitabine
Drug Approval | April 27, 2024

CHMP adopts positive opinion recommending approval of Bristol Myers Squibb’s Opdivo in combination with Cisplatin and Gemcitabine

If approved, the Opdivo-based regimen would be the first immunotherapy-chemotherapy combination approved for this patient population in the EU


Takeda receives positive CHMP opinion for Fruquintinib in previously treated mCRC
Drug Approval | April 27, 2024

Takeda receives positive CHMP opinion for Fruquintinib in previously treated mCRC

If approved in the European Union, Fruquintinib will be the first novel targeted therapy for Metastatic Colorectal Cancer regardless of biomarker status in over a decade


Voydeya approved in the EU as add-on treatment to ravulizumab
News | April 23, 2024

Voydeya approved in the EU as add-on treatment to ravulizumab

ALPHA Phase III trial showed first-in-class, oral, Factor D inhibitor as add-on to Ultomiris or Soliris improved haemoglobin levels and reduced anaemia and fatigue