FDA grants fast review of AZ’s Brilinta to prevent recurring strokesThe FDA has granted a fast review of AstraZeneca’s cardiovascular diseases drug Brilinta (ticagrelor) in the new indication that aims to reduce Share XFDA grants fast review of AZ’s Brilinta to prevent recurring strokeshttps://pharmaphorum.com/news/az-grants-fast-review-of-astrazenecas-cardiovascular-diseases-drug-brilinta/
FDA backs second rare disease drug from Ultragenyx in the space of a fortnightThe FDA has approved a second rare disease drug from California-based Ultragenyx in the space of a fortnight, for treatment Share XFDA backs second rare disease drug from Ultragenyx in the space of a fortnighthttps://pharmaphorum.com/news/fda-backs-ultragenyxs-second-rare-disease-drug-in-the-space-of-a-fortnight/
Merck & Co’s Keytruda gets new colorectal cancer use after month-long FDA reviewIt’s barely a month since Merck & Co unveiled trial results showing that cancer immunotherapy Keytruda (pembrolizumab) works in colorectal Share XMerck & Co’s Keytruda gets new colorectal cancer use after month-long FDA reviewhttps://pharmaphorum.com/news/merck-cos-keytruda-gets-new-colorectal-cancer-use-after-month-long-fda-review/
Intercept CEO lays into FDA after NASH drug rejectionIntercept Pharmaceuticals has accused the FDA of moving the goalposts during its review of a potential blockbuster drug for the fatty Share XIntercept CEO lays into FDA after NASH drug rejectionhttps://pharmaphorum.com/news/intercept-ceo-lays-into-fda-after-nash-drug-rejection/
FDA approves Akili’s video game ADHD therapyThe FDA has approved the first video game-based treatment for attention deficit hyperactivity disorder (ADHD), from Akili. Called EndeavorRx, Share XFDA approves Akili’s video game ADHD therapyhttps://pharmaphorum.com/news/fda-approves-akilis-video-game-adhd-therapy/
FDA defies Trump and revokes emergency authorisation for hydroxychloroquineThe FDA has revoked its Emergency Use Authorization for hydroxychloroquine as a treatment for COVID-19, drawing the ire of president Donald Share XFDA defies Trump and revokes emergency authorisation for hydroxychloroquinehttps://pharmaphorum.com/news/fda-defies-trump-and-revokes-emergency-authorisation-for-hydroxychloroquine/
FDA extends review of Novartis’ MS drug ofatumumabThe FDA has extended its review of Novartis’ potential multiple sclerosis drug ofatumumab, pushing back a decision on the repurposed Share XFDA extends review of Novartis’ MS drug ofatumumabhttps://pharmaphorum.com/news/fda-extends-review-of-novartis-ms-drug-ofatumumab/
FDA hastens development of Novartis’ Kymriah in follicular lymphomaNovartis will receive extra help from the FDA during the development of its CAR-T cancer cell therapy Kymriah Share XFDA hastens development of Novartis’ Kymriah in follicular lymphomahttps://pharmaphorum.com/news/fda-hastens-development-of-novartis-kymriah-in-follicular-lymphoma/
FDA backs first COVID-19 test with home collection optionThe FDA has backed the first COVID-19 diagnostic with a home collection option, at a time when the Share XFDA backs first COVID-19 test with home collection optionhttps://pharmaphorum.com/news/fda-backs-first-covid-19-test-with-home-collection-option/
