regulatory

News

Surgeon with surgical gloves on holding a brain scan

Lilly to appeal after CHMP rejects Alzheimer's drug Kisunla

The CHMP has advised against EU approval of Eli Lilly's Alzheimer's drug Kisunla, potentially handing an advantage to Eisai/Biogen's rival drug.

News

HHS plans 10,000 more job cuts, taking target to 20,000

HHS Secretary Kennedy has said he intends to save $1.8bn per year, thanks to another wave of job cuts affecting the FDA, CDC, NIH, and CMS.

News

Jean-François Toussaint, Sanofi's global head of vaccines R&D

FDA fast-tracks Sanofi's experimental chlamydia vaccine

Sanofi is preparing to start human testing of its chlamydia vaccine, now fast-tracked by the FDA, that it hopes will be the first to reach the market.

News

FDA starts review of Sanofi's MS hope tolebrutinib

Sanofi's oral BTK inhibitor tolebrutinib is heading towards an FDA decision in September as a potential treatment for multiple sclerosis.

News

EMA panel endorses AI for MASH clinical trials

PathAI's artificial intelligence tool for diagnosing MASH has become the first to be recommended under the EMA's Qualification Opinion framework.

News

J&J's nipocalimab fast-tracked for Sjogren's disease

Johnson & Johnson's FcRn inhibitor nipocalimab has been awarded fast-track status by the FDA as a treatment for Sjogren's disease.

Lilly to appeal after CHMP rejects Alzheimer's drug Kisunla

HHS plans 10,000 more job cuts, taking target to 20,000

FDA fast-tracks Sanofi's experimental chlamydia vaccine

FDA starts review of Sanofi's MS hope tolebrutinib

EMA panel endorses AI for MASH clinical trials

J&J's nipocalimab fast-tracked for Sjogren's disease

Iterum brings first oral penem antibiotic to US market

The value of a partner, globally and locally

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
-Life Sciences Industry Report
-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
-Life Sciences Industry Report
-Understanding HCPs
-World Without Disease Summit
-The Future of Generics

regulatory

Editor's Picks