Tags : EMA’s

Novartis Reports Acceptance of Ofatumumab’s (OMB157) sBLA from the US

Vartika Singh February 24, 2020

Shots: The approval is based on P-III ASCLEPIOS I and II studies involves assessing of ofatumumab (20mg, SC) vs Aubagio (14mg oral tablets) in 1882 adults with MS between the […]readmore

Regulatory

Rafael Pharmaceuticals’ Devimistat (CPI-613) Receives EMA’s ODD for R/R Acute

Vartika Singh January 11, 2019

Shots: The ODD designation is based on the study results assessing devimistat + high dose cytarabine & mitoxantrone and devimistat + folfirinox in patients with r/r AML and mPC […]readmore

Tags : EMA’s

Novartis Reports Acceptance of Ofatumumab’s (OMB157) sBLA from the US

Rafael Pharmaceuticals’ Devimistat (CPI-613) Receives EMA’s ODD for R/R Acute

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PharmaShots Weekly Snapshots (November 15 – 19, 2021)

Jazz’ Sunosi (solriamfetol) Receives NICE Recommendation for the Treatment of Excessive Daytime Sleepiness Caused by Narcolepsy

Antengene’s Selinexor (ATG-010) Receives NMPA’s IND Approval for P-I/II SWATCH Study to Treat Non-Hodgkin Lymphoma

Daiichi Sankyo Reports Results of Quizartinib in P-III QuANTUM-First Trial for the Treatment of FLT3-ITD Positive AML

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Tags : EMA’s

Novartis Reports Acceptance of Ofatumumab’s (OMB157) sBLA from the US

Rafael Pharmaceuticals’ Devimistat (CPI-613) Receives EMA’s ODD for R/R Acute

Latest Posts

PharmaShots Weekly Snapshots (November 15 – 19, 2021)

Jazz’ Sunosi (solriamfetol) Receives NICE Recommendation for the Treatment of Excessive Daytime Sleepiness Caused by Narcolepsy

Antengene’s Selinexor (ATG-010) Receives NMPA’s IND Approval for P-I/II SWATCH Study to Treat Non-Hodgkin Lymphoma

Daiichi Sankyo Reports Results of Quizartinib in P-III QuANTUM-First Trial for the Treatment of FLT3-ITD Positive AML

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