European Medicines Agency
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U.S. Food & Drug Administration Grants Priority Review of Maribavir for the Treatment of Post-Transplant Recipients With Cytomegalovirus Infection in Those Resistant and/or Refractory to Prior Anti-CMV Treat
Osaka, Japan: − If Approved, Maribavir Will Be the First and Only Treatment Indicated for Post-Transplant Cytomegalovirus (CMV) Infection in…
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LEO Pharma Receives Positive CHMP Opinion of Adtralza® (tralokinumab) for the Treatment of Adults With Moderate-to-Severe Atopic Dermatitis
NOT FOR DISTRIBUTION IN THE UK OR IRELAND If authorized, Adtralza® (tralokinumab) will be the first approved biologic that specifically…
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LintonPharm Announces Authorization from China Health Authority (NMPA) to Proceed with a Phase 1/2 Trial Evaluating Catumaxomab for the treatment of Non-Muscle Invasive Bladder Cancer
Guangzhou, China: LintonPharm Co., Ltd., a China-based clinical stage biopharmaceutical company focused on the development of T cell engaging bispecific…
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VFMCRP and Cara Therapeutics announce European Medicines Agency has accepted to review the Marketing Authorization Application for difelikefalin
Companies have successfully submitted the EU regulatory application for marketing authorization for difelikefalin If approved, difelikefalin injection will be the…
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Orphan Drug Designation Granted to Rezafungin in EU for the Treatment of Invasive Candidiasis
Cambridge, United Kingdom & San Diego, United States: Invasive candidiasis (IC) is characterised as a severe, life-threatening Candida infection of the bloodstream…
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Boehringer Ingelheim receives positive CHMP opinion for use of Pradaxa® (dabigatran etexilate) for the treatment and prevention of venous thromboembolic events in children from birth to less than 18 years of age
Ingelheim, Germany: No approved therapy for the treatment and prevention of venous thromboembolic events in children until now Current standard…
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VFMCRP and ChemoCentryx announce European Medicines Agency has accepted to review the Marketing Authorization Application for avacopan
St. Gallen, Switzerland & Mountain View, Calif., United States: Companies have completed the EU regulatory application for marketing approval of…
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