Headache for Zosano as FDA turns down migraine patchZosano Pharma has been hit by an FDA rejection of its marketing application for migraine drug Qtrypta, asking Share XHeadache for Zosano as FDA turns down migraine patchhttps://pharmaphorum.com/news/headache-for-zosano-as-fda-turns-down-migraine-patch/
Pfizer to wait until after election to file COVID-19 vaccine in USPfizer said it will wait until after the US election to file its COVID-19 vaccine with the US Share XPfizer to wait until after election to file COVID-19 vaccine in UShttps://pharmaphorum.com/news/pfizer-to-wait-until-after-election-to-file-covid-19-vaccine-in-us/
Scynexis bids to end novel antifungal drought, filing ibrexafungerp in USScynexis has filed for FDA approval of its novel drug ibrexafungerp which – if approved – would be Share XScynexis bids to end novel antifungal drought, filing ibrexafungerp in UShttps://pharmaphorum.com/news/scynexis-bids-to-end-novel-antifungal-drought/
Harmony’s sleep disorder drug Wakix gets US label extensionHarmony Biosciences has scored an expanded use for its Wakix narcolepsy drug to include cataplexy – a symptom Share XHarmony’s sleep disorder drug Wakix gets US label extensionhttps://pharmaphorum.com/news/harmonys-narcolepsy-drug-gets-extended-cataplexy/
Lilly pauses COVID-19 antibody trial after factory hits trouble with FDAEli Lilly has put a clinical trial of its COVID-19 antibody therapy on hold after FDA inspectors found Share XLilly pauses COVID-19 antibody trial after factory hits trouble with FDAhttps://pharmaphorum.com/news/lilly-pauses-covid-19-antibody-trial-after-factory-hits-trouble-with-fda/
FDA gives COVID-19 vaccine ‘advice’ after White House blocks guidanceThe FDA may have been blocked from issuing stricter guidelines for emergency approval of COVID-19 vaccines by the Share XFDA gives COVID-19 vaccine ‘advice’ after White House blocks guidancehttps://pharmaphorum.com/news/fda-gives-covid-19-vaccine-advice-after-white-house-blocks-guidance/
EMA review of AZ’s COVID-19 vaccine imminent; reportThe EU regulator is poised to start a review of AstraZeneca and Oxford University’s COVID-19 vaccine, but the Share XEMA review of AZ’s COVID-19 vaccine imminent; reporthttps://pharmaphorum.com/news/ema-review-of-azs-covid-19-vaccine-imminent-report/
CTI wins over FDA to claim early review of myelofibrosis drugShares in US biotech CTI BioPharma have shot up after the FDA agreed to an accelerated review early Share XCTI wins over FDA to claim early review of myelofibrosis drughttps://pharmaphorum.com/news/cti-wins-over-fda-to-claim-early-review-of-myelofibrosis-drug/
FDA slams brakes on Inovio’s final-stage COVID-19 vaccine trialsInovio Pharma’s plan to start pivotal testing of its COVID-19 vaccine has been delayed by FDA requests for Share XFDA slams brakes on Inovio’s final-stage COVID-19 vaccine trialshttps://pharmaphorum.com/news/fda-slams-brakes-on-inovio-final-stage-covid-19-vaccine-trials/
