regulatory approval

News

Enhertu gets first okay for HER2-ultralow breast cancer

Enhertu gets much-anticipated new FDA approval in breast cancer that expands its label and makes it an earlier option in the treatment pathway.

News

J&J's Spravato gets another lift with new FDA approval

Johnson & Johnson's Spravato has become the first standalone drug to be cleared by the FDA for adults with treatment-resistant depression.

News

EU approves endometrial, lung cancer drugs from GSK and J&J

Both GSK and J&J have claimed pivotal approvals for growth-phase oncology therapies in the EU.

News

AZ, Daiichi get FDA nod for Dato-DXd in breast cancer

AstraZeneca and Daiichi Sankyo have claimed FDA approval for a second antibody-drug conjugate for breast cancer - TROP2-directed Datroway.

News

Amgen picks up key colorectal cancer okay for KRAS drug

Can a new FDA approval in colorectal cancer kickstart sales growth for Amgen's KRAS inhibitor Lumakras?

News

Microscope view of nodular mantle cell lymphoma

AZ's Calquence gets first-line OK in mantle cell lymphoma

AstraZeneca's BTK inhibitor Calquence is the first drug in the class to be approved in the US for first-line treatment of mantle cell lymphoma.

Enhertu gets first okay for HER2-ultralow breast cancer

J&J's Spravato gets another lift with new FDA approval

EU approves endometrial, lung cancer drugs from GSK and J&J

AZ, Daiichi get FDA nod for Dato-DXd in breast cancer

Amgen picks up key colorectal cancer okay for KRAS drug

AZ's Calquence gets first-line OK in mantle cell lymphoma

Chaos & opportunity: Dr Adam Brown unpacks US health policy

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