regulatory approval

News

GBT claims EU approval for sickle cell drug Oxbryta

Global Blood Therapeutics' run of positive regulatory news for its oral sickle cell disease treatment Oxbryta has continued with an approval for the drug in Europe for patients aged over 12

News

AZ's lupus drug Saphnelo cleared in EU, challenging GSK's Be...

AstraZeneca's Saphnelo has become the first new drug to be approved to treat the autoimmune disease systemic lupus erythematosus (SLE) in the EU for more than 10 years.

News

Sanofi claims FDA okay for drug to treat rare blood disorder...

Sanofi has won FDA approval for its sutimlimab for cold agglutinin disease (CAD) at the second time of asking, becoming the first approved therapy for the rare blood disorder in the US.

News

Roche grabs FDA okay for would-be blockbuster eye drug faric...

The FDA has approved Roche's much-anticipated faricimab for two major causes of blindness, setting up a market clash with Bayer and Regeneron's market leading drug Eylea.

News

Merck gets EU nod for Keytruda in adjuvant kidney cancer

Merck & Co has passed another milestone in its drive to move PD-1 inhibitor Keytruda earlier in the treatment pathway for cancer, with the European Commission approving use of the drug

News

Immunocore claims first-ever FDA approval for TCR cancer the...

Immunocore has secured a piece of biotech industry history, becoming the first company to get an FDA approval for a cancer therapeutic based on T cell receptor (TCR) technology.

GBT claims EU approval for sickle cell drug Oxbryta

AZ's lupus drug Saphnelo cleared in EU, challenging GSK's Be...

Sanofi claims FDA okay for drug to treat rare blood disorder...

Roche grabs FDA okay for would-be blockbuster eye drug faric...

Merck gets EU nod for Keytruda in adjuvant kidney cancer

Immunocore claims first-ever FDA approval for TCR cancer the...

FDA probing cancer cases with Bluebird's CALD gene therapy

Coming soon: The Life Sciences Industry Report 2025 – insigh...

Others Old
-About pharmaphorum
-Articles
--eyeforpharma Barcelona 2015
-Audio
-barelonalive 2016
-Cancer
-Diabetes
--Diabetes
-Disease Spotlight
--DMD Main
--LHON Main
-ESMO2016
-ESMO2016-related
-Event coverage
--ASCO-slider
--ASCO-pp
--ASCO-contributor
--ASCO 2018
-Featured content right column
-Featured Event
-Jobs
--pharmaphorum-live
-Medical Affairs Spotlight
--Medical Affairs Spotlight - partner
--Medical Affairs Spotlight - main
-Podcast
-Premium media
-Quintiles
--Quintiles-oncol-PC
--Quintiles - ContentIO
--Quintiles - Articles
--Quintiles - Oncol articles
-Roundtables
--AZ-roundtable-biographies-2017
--AZ-roundtable-interviews-2017
--AZ-roundtable-debate-2017
-Sales and Marketing
--News
--Insights
--Appointments
--Debates
--Debates & Insight
--Views & Analysis
--Partner Content
-Slider in events
-Slider in home page
-Slider in video
-Slider in views and analysis
-Slider in webinars
-Slider in whitepapers
-Spotlight
--Understanding HCPs
--Future of Generics
--Frontiers Health 2022
--Frontiers Health 2021
--Behavioural Science
--ASCO 2019 Live coverage
--AI in Pharma Marketing
--ASCO 2019 and the future of oncology
-Startups
--Views & Analysis
--News
-System
-Top pharmaceutical companies
--Bristol-Myers Squibb
--Teva
--Roche
--Pfizer
--Novo Nordisk
--Novartis
--Merck Inc
--GlaxoSmithKline
--Gilead
--AstraZeneca
--AbbVie
-Top pharmaceutical companies
--Merck Inc
-Top stories
-Transversal Categories
--Brexit
--Clinical
--Digital and Social Media
--US
---Articles
--UK & Europe
--Sales and Marketing
--Rare diseases
--R&D
--Pharma Market Access
--M&A
--Healthcare
-Veeva
-Veeva channel content articles
-Veeva channel content webinars
-Video
-Views and analysis
-Webinars in home page
-Whitepapers
Others
-Transversal Categories
--Sustainability
--Clinical
--Brexit
--Digital and Social Media
--Healthcare
--US
--UK & Europe
--Sales & Marketing
--Rare diseases
--R&D
--Pharma Market Access
--M&A
-Top stories
-About pharmaphorum
-Top pharmaceutical companies
--Gilead
--Merck Inc
--Teva
--Roche
--Pfizer
--Novo Nordisk
--Novartis
--GlaxoSmithKline
--Bristol-Myers Squibb
--AstraZeneca
--AbbVie
-test webinar
-System
-Startups
--News
--Views & Analysis
-Veeva channel content webinars
-Webinars in home page
--Live webinar
--Webinars On demand
-Veeva channel content articles
-Veeva
-Spotlight
-Event coverage
--ASCO-slider
--ASCO-pp
--ASCO-contributor
--ASCO 2018
-ESMO2016-related
-ESMO2016
-Featured Event
-Disease Spotlight
--LHON Main
--DMD Main
-Diabetes
--Diabetes
-Cancer
-barelonalive 2016
-Audio
-Articles
--eyeforpharma Barcelona 2015
-Slider in whitepapers
-Featured content right column
-Jobs
--pharmaphorum-live
-Roundtables
--AZ-roundtable-interviews-2017
--AZ-roundtable-biographies-2017
--AZ-roundtable-debate-2017
-Slider in webinars
-Slider in views and analysis
-Slider in video
-Slider in home page
-Slider in events
-Quintiles
--Quintiles-oncol-PC
--Quintiles - Oncol articles
--Quintiles - ContentIO
--Quintiles - Articles
-Premium media
-Medical Affairs Spotlight
--Medical Affairs Spotlight - partner
--Medical Affairs Spotlight - main
Home
-News
-Views & Analysis
-Deep Dive
-Webinars
--Live webinar
-Podcasts
-Videos
-White Papers
-Events
--JP Morgan
--LSX Investech
--Anthropy
--Reuters Pharma 2022
--World Cancer Series
--Hlth 2022
--PM Society Awards
--Patient Summit PC
--Frontiers Health 2022
--FHlive17
--ASCO 2018
-Digital Debates
-Podcasts & Videos
-Partner Content
--Events
--News
--Appointments
--Press releases
Digital
-Appointments
-Debates
-Insights
-News
-Press Releases
-Views & Analysis
-Deep Dive
-Webinars
-Podcasts
-Video
-White Papers
-Event
-Debates & Insight
-Partner Content
Market Access
-Debates
-Insights
-News
-Press Releases
-Views & Analysis
-Deep Dive
-Webinars
-Podcasts
-Video
-White Papers
-Event
-Debates & Insight
-Partner Content
Oncology
-Appointments
-Debates
-Insights
-News
-Views & Analysis
-Deep Dive
-Webinars
-Podcasts
-Video
-White Papers
-Event
-Debates & Insight
-Partner Content
Patients
-Debates
-Insights
-News
-Press Releases
-Views & Analysis
-Deep Dive
-Webinars
-Podcasts
-Video
-White Papers
-Event
-Debates & Insight
-Partner Content
R&D
-Appointments
-Debates
-Debates & Insights
-Insights
-News
-Press Releases
-Views & Analysis
-Deep Dive
-Webinars
-Podcasts
-Video
-White Papers
-Event
-Partner Content
-Debates & Insight
Sales & Marketing
-Debates
-Insights
-News
-Press Releases
-Views & Analysis
-Deep Dive
-Webinars
-Podcasts
-Video
-White Papers
-Event
-Debates & Insight
-Partner Content
Spotlight on
-AI in Pharma Marketing
-ASCO 2019 and the future of oncology
-ASCO 2019 Live coverage
-Behavioural Science
-Frontiers Health 2021
-Frontiers Health 2022
-Frontiers Health 2023
-Frontiers Health 2024
-Future of Generics
-Understanding HCPs
-World Without Disease Summit
-The Future of Generics

Others Old
-About pharmaphorum
-Articles
--eyeforpharma Barcelona 2015
-Audio
-barelonalive 2016
-Cancer
-Diabetes
--Diabetes
-Disease Spotlight
--DMD Main
--LHON Main
-ESMO2016
-ESMO2016-related
-Event coverage
--ASCO-slider
--ASCO-pp
--ASCO-contributor
--ASCO 2018
-Featured content right column
-Featured Event
-Jobs
--pharmaphorum-live
-Medical Affairs Spotlight
--Medical Affairs Spotlight - partner
--Medical Affairs Spotlight - main
-Podcast
-Premium media
-Quintiles
--Quintiles-oncol-PC
--Quintiles - ContentIO
--Quintiles - Articles
--Quintiles - Oncol articles
-Roundtables
--AZ-roundtable-biographies-2017
--AZ-roundtable-interviews-2017
--AZ-roundtable-debate-2017
-Sales and Marketing
--News
--Insights
--Appointments
--Debates
--Debates & Insight
--Views & Analysis
--Partner Content
-Slider in events
-Slider in home page
-Slider in video
-Slider in views and analysis
-Slider in webinars
-Slider in whitepapers
-Spotlight
--Understanding HCPs
--Future of Generics
--Frontiers Health 2022
--Frontiers Health 2021
--Behavioural Science
--ASCO 2019 Live coverage
--AI in Pharma Marketing
--ASCO 2019 and the future of oncology
-Startups
--Views & Analysis
--News
-System
-Top pharmaceutical companies
--Bristol-Myers Squibb
--Teva
--Roche
--Pfizer
--Novo Nordisk
--Novartis
--Merck Inc
--GlaxoSmithKline
--Gilead
--AstraZeneca
--AbbVie
-Top pharmaceutical companies
--Merck Inc
-Top stories
-Transversal Categories
--Brexit
--Clinical
--Digital and Social Media
--US
---Articles
--UK & Europe
--Sales and Marketing
--Rare diseases
--R&D
--Pharma Market Access
--M&A
--Healthcare
-Veeva
-Veeva channel content articles
-Veeva channel content webinars
-Video
-Views and analysis
-Webinars in home page
-Whitepapers
Others
-Transversal Categories
--Sustainability
--Clinical
--Brexit
--Digital and Social Media
--Healthcare
--US
--UK & Europe
--Sales & Marketing
--Rare diseases
--R&D
--Pharma Market Access
--M&A
-Top stories
-About pharmaphorum
-Top pharmaceutical companies
--Gilead
--Merck Inc
--Teva
--Roche
--Pfizer
--Novo Nordisk
--Novartis
--GlaxoSmithKline
--Bristol-Myers Squibb
--AstraZeneca
--AbbVie
-test webinar
-System
-Startups
--News
--Views & Analysis
-Veeva channel content webinars
-Webinars in home page
--Live webinar
--Webinars On demand
-Veeva channel content articles
-Veeva
-Spotlight
-Event coverage
--ASCO-slider
--ASCO-pp
--ASCO-contributor
--ASCO 2018
-ESMO2016-related
-ESMO2016
-Featured Event
-Disease Spotlight
--LHON Main
--DMD Main
-Diabetes
--Diabetes
-Cancer
-barelonalive 2016
-Audio
-Articles
--eyeforpharma Barcelona 2015
-Slider in whitepapers
-Featured content right column
-Jobs
--pharmaphorum-live
-Roundtables
--AZ-roundtable-interviews-2017
--AZ-roundtable-biographies-2017
--AZ-roundtable-debate-2017
-Slider in webinars
-Slider in views and analysis
-Slider in video
-Slider in home page
-Slider in events
-Quintiles
--Quintiles-oncol-PC
--Quintiles - Oncol articles
--Quintiles - ContentIO
--Quintiles - Articles
-Premium media
-Medical Affairs Spotlight
--Medical Affairs Spotlight - partner
--Medical Affairs Spotlight - main
Home
-News
-Views & Analysis
-Deep Dive
-Webinars
--Live webinar
-Podcasts
-Videos
-White Papers
-Events
--JP Morgan
--LSX Investech
--Anthropy
--Reuters Pharma 2022
--World Cancer Series
--Hlth 2022
--PM Society Awards
--Patient Summit PC
--Frontiers Health 2022
--FHlive17
--ASCO 2018
-Digital Debates
-Podcasts & Videos
-Partner Content
--Events
--News
--Appointments
--Press releases
Digital
-Appointments
-Debates
-Insights
-News
-Press Releases
-Views & Analysis
-Deep Dive
-Webinars
-Podcasts
-Video
-White Papers
-Event
-Debates & Insight
-Partner Content
Market Access
-Debates
-Insights
-News
-Press Releases
-Views & Analysis
-Deep Dive
-Webinars
-Podcasts
-Video
-White Papers
-Event
-Debates & Insight
-Partner Content
Oncology
-Appointments
-Debates
-Insights
-News
-Views & Analysis
-Deep Dive
-Webinars
-Podcasts
-Video
-White Papers
-Event
-Debates & Insight
-Partner Content
Patients
-Debates
-Insights
-News
-Press Releases
-Views & Analysis
-Deep Dive
-Webinars
-Podcasts
-Video
-White Papers
-Event
-Debates & Insight
-Partner Content
R&D
-Appointments
-Debates
-Debates & Insights
-Insights
-News
-Press Releases
-Views & Analysis
-Deep Dive
-Webinars
-Podcasts
-Video
-White Papers
-Event
-Partner Content
-Debates & Insight
Sales & Marketing
-Debates
-Insights
-News
-Press Releases
-Views & Analysis
-Deep Dive
-Webinars
-Podcasts
-Video
-White Papers
-Event
-Debates & Insight
-Partner Content
Spotlight on
-AI in Pharma Marketing
-ASCO 2019 and the future of oncology
-ASCO 2019 Live coverage
-Behavioural Science
-Frontiers Health 2021
-Frontiers Health 2022
-Frontiers Health 2023
-Frontiers Health 2024
-Future of Generics
-Understanding HCPs
-World Without Disease Summit
-The Future of Generics

regulatory approval

Editor's Picks