Erenumab (AIMOVIG™): First Global Approval in US followed by Positive CHMP Opinion – Once-monthly prophylactic approach for adults with Migraine

Erenumab (AIMOVIG™): First Global Approval in US followed by Positive CHMP Opinion – Once-monthly prophylactic approach for adults with Migraine

Erenumab (AIMOVIG™, erenumab-aooe) was launched in the US in July 2018, following its first global approval in the region in May, which was reviewed in detail in the First Global Approval report in Adis’ journal Drugs[1], based on the development milestones tracked in AdisInsight[2]. Also in May 2018, the agent received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP). Continue reading “Erenumab (AIMOVIG™): First Global Approval in US followed by Positive CHMP Opinion – Once-monthly prophylactic approach for adults with Migraine”

Tivozanib (Fotiva®): First Global Approval – selective agent for optimal VEGF blockade in adults with renal cell carcinoma.

Tivozanib (Fotiva®): First Global Approval – selective agent for optimal VEGF blockade in adults with renal cell carcinoma.

The recent first global approval of tivozanib has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs[1], based on the development milestones tracked in AdisInsight[2]. Continue reading “Tivozanib (Fotiva®): First Global Approval – selective agent for optimal VEGF blockade in adults with renal cell carcinoma.”

Glecaprevir/Pibrentasvir (MAVIRET™): First Global Approval in Europe – then BAM! Anti-viral approval spreads rapidly across the globe!!

Glecaprevir/Pibrentasvir (MAVIRET™): First Global Approval in Europe – then BAM! Anti-viral approval spreads rapidly across the globe!!

The recent first global approval of glecaprevir/pibrentasvir has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs[1], based on the development milestones tracked in AdisInsight[2]. Continue reading “Glecaprevir/Pibrentasvir (MAVIRET™): First Global Approval in Europe – then BAM! Anti-viral approval spreads rapidly across the globe!!”

Inotuzumab Ozogamicin (Besponsa®): First Global Approval – targeted treatment for Adults with relapsed or recurrent B-cell acute lymphoblastic leukaemia

Inotuzumab Ozogamicin (Besponsa®): First Global Approval – targeted treatment for Adults with relapsed or recurrent B-cell acute lymphoblastic leukaemia

The recent first global approval of inotuzumab ozogamicin has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs[1], based on the development milestones tracked in AdisInsight[2]. Continue reading “Inotuzumab Ozogamicin (Besponsa®): First Global Approval – targeted treatment for Adults with relapsed or recurrent B-cell acute lymphoblastic leukaemia”