regulatory approval

News

Neurotech's cell therapy gets FDA nod for eye disorder MacTe...

Neurotech Pharma's cell therapy Encelto has become the first FDA-approved therapy for idiopathic macular telangiectasia type 2.

News

Roche ends the 30-year US hiatus in new stroke drugs

Genentech has won FDA approval for its clot-buster TNKase as a treatment for acute ischaemic stroke, after almost abandoning the project in 2023.

News

FDA clears first therapy for rare disease CTX from Mirum

Mirum Pharma's Ctexli has become the first FDA-approved therapy for ultra-rare disease cerebrotendinous xanthomatosis (CTX).

News

Shionogi gets approval in Japan for ADHD digital therapeutic

Shionogi will market the EndeavorRide app, originally licensed from Akili, in Japan following its approval by the MHLW regulator.

News

First biosimilar fast-acting insulin reaches US market

Sanofi has claimed FDA approval for the first biosimilar of Novo Nordisk's rapid-acting insulin analogue Novolog.

News

Bavarian Nordic chikungunya vaccine gets FDA okay

There are now two vaccines to protect against chikungunya approved for use in the US, after Bavarian Nordic gets the green light for Vimkunya.

Neurotech's cell therapy gets FDA nod for eye disorder MacTe...

Roche ends the 30-year US hiatus in new stroke drugs

FDA clears first therapy for rare disease CTX from Mirum

Shionogi gets approval in Japan for ADHD digital therapeutic

First biosimilar fast-acting insulin reaches US market

Bavarian Nordic chikungunya vaccine gets FDA okay

Axtria Ignite 2025: Madhavi Ramakrishna on leadership, cultu...

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 approval

Editor's Picks