FDA delays decision on Roche’s SMA drug to review extra dataThe FDA has extended its review of Roche’s spinal muscular atrophy (SMA) drug risdiplam after the pharma submitted Share XFDA delays decision on Roche’s SMA drug to review extra datahttps://pharmaphorum.com/news/fda-delays-decision-on-roches-sma-drug-to-review-extra-data/
FDA lets off Novartis after gene therapy data rowNovartis is off the hook following the FDA’s review of data manipulation in the filing of its hugely Share XFDA lets off Novartis after gene therapy data rowhttps://pharmaphorum.com/news/fda-lets-off-novartis-after-gene-therapy-data-row/
FDA grants emergency use of malaria drugs against COVID-19The FDA has approved emergency use of malaria drugs championed by president Donald Trump for use in patients Share XFDA grants emergency use of malaria drugs against COVID-19https://pharmaphorum.com/news/fda-grants-emergency-use-of-malaria-drugs-against-covid-19/
FDA backs Glenmark’s rival to AZ’s blockbuster FarxigaAstraZeneca’s diabetes drug Farxiga could face generic competition in the US, after the FDA gave tentative approval to Share XFDA backs Glenmark’s rival to AZ’s blockbuster Farxigahttps://pharmaphorum.com/news/fda-tentatively-backs-glenmarks-farxiga-generic/
FDA approves fast tests for coronavirus as US faces shortagesThe FDA has approved two fast tests for the coronavirus that is causing the COVID-19 epidemic, which are Share XFDA approves fast tests for coronavirus as US faces shortageshttps://pharmaphorum.com/news/fda-approves-fast-tests-for-coronavirus-as-us-faces-shortages/
Janssen files MS pill, ahead of FDA decision on BMS’ rivalJanssen has filed its ponesimod pill with the FDA for treatment of adults with relapsing multiple sclerosis, days Share XJanssen files MS pill, ahead of FDA decision on BMS’ rivalhttps://pharmaphorum.com/news/janssen-files-ms-pill-ahead-of-fda-decision-on-bms-rival/
FDA guides on running clinical trials during coronavirus outbreakThe FDA has responded to concerns about the impact on clinical trials of the novel coronavirus with guidance Share XFDA guides on running clinical trials during coronavirus outbreakhttps://pharmaphorum.com/news/fda-guides-on-handling-clinical-trials-during-coronavirus-outbreak/
‘Predatory’ drugmakers exploit FDA’s unapproved drug scheme; studyAn FDA mechanism designed to curb unapproved uses of medicines could be encouraging pharma companies to implement massive Share X‘Predatory’ drugmakers exploit FDA’s unapproved drug scheme; studyhttps://pharmaphorum.com/news/predatory-drugmakers-exploit-fdas-unapproved-drug-scheme-study/
FDA starts review of Pfizer, Lilly’s non-opioid painkillerAfter years in development, the FDA has started its review of Pfizer and Eli Lilly’s new painkiller tanezumab, Share XFDA starts review of Pfizer, Lilly’s non-opioid painkillerhttps://pharmaphorum.com/news/fda-starts-review-of-pfizer-lillys-non-opioid-painkiller/
