Eli Lilly, Incyte axe Olumiant in lupus amid eczema stalemate at FDA
Eli Lilly, Incyte axe Olumiant in lupus amid eczema stalemate [...]
Unable to ‘align’ with FDA, Regeneron, Sanofi pull application for Libtayo in cervical cancer days before decision date
Unable to ‘align’ with FDA, Regeneron, Sanofi pull application for [...]
Fierce Pharma Asia—Samsung Biologics’ mRNA ambition, GSK COVID-19 vaccine supply; Fujifilm’s plant buy
Fierce Pharma Asia—Samsung Biologics’ mRNA ambition, GSK COVID-19 vaccine supply; [...]
Yet another delay at Amryt as EMA calls in experts to inform review of rare disease drug
Yet another delay at Amryt as EMA calls in experts [...]
Homology scratches cash itch with manufacturing deal, bagging $130M to fund gene therapy trials
Homology scratches cash itch with manufacturing deal, bagging $130M to [...]
Pfizer in Texas showdown: Court hearing this week will decide if it can assist FDA in providing COVID documents
Pfizer in Texas showdown: Court hearing this week will decide [...]
Taysha mulls tweaks to gene therapy trial after subject dies
Taysha mulls tweaks to gene therapy trial after subject dies [...]
FDA slaps Aurobindo with warning letter on API testing failures, repeated violations
FDA slaps Aurobindo with warning letter on API testing failures, [...]
Novo Nordisk’s Wegovy, hamstrung by Catalent FDA write-up, could correct course by mid-2022: analysts
Novo Nordisk’s Wegovy, hamstrung by Catalent FDA write-up, could correct [...]
Neck and neck with Pfizer, Moderna gives first dose of omicron-specific booster in phase 2 trial
Neck and neck with Pfizer, Moderna gives first dose of [...]