BMS pulls speedy Opdivo approval for liver cancer in USBristol-Myers Squibb has withdrawn its US marketing approval for PD-1 inhibitor Opdivo as a second-line, single-agent treatment for Share XBMS pulls speedy Opdivo approval for liver cancer in UShttps://pharmaphorum.com/news/bms-pulls-speedy-opdivo-approval-in-liver-cancer-in-us/
Novartis eyes New Year verdict from FDA on delayed LeqvioNovartis has revealed that the FDA has accepted its resubmission for cholesterol-lowering drug Leqvio – rejected unexpectedly by Share XNovartis eyes New Year verdict from FDA on delayed Leqviohttps://pharmaphorum.com/news/novartis-eyes-new-year-verdict-from-fda-on-delayed-leqvio/
Hard times at Ardelyx as FDA rejects kidney disease drug tenapanorThe FDA has taken a longer than usual look at Ardelyx’s regulatory submission for tenapanor, a drug for Share XHard times at Ardelyx as FDA rejects kidney disease drug tenapanorhttps://pharmaphorum.com/news/hard-times-at-ardelyx-as-fda-rejects-kidney-disease-drug-tenapanor/
FDA okays Merck’s would-be Prevnar rival VaxneuvanceThe FDA has approved a new pneumococcal vaccine from Merck & Co, just over a month after Pfizer Share XFDA okays Merck’s would-be Prevnar rival Vaxneuvancehttps://pharmaphorum.com/news/fda-okays-mercks-would-be-prevnar-rival-vaxneuvance/
FDA adcomm turns down FibroGen, AZ’s roxadustat for CKD anaemiaSafety concerns seem to have scuppered any hope of a near-term approval for FibroGen and AstraZeneca’s roxadustat for Share XFDA adcomm turns down FibroGen, AZ’s roxadustat for CKD anaemiahttps://pharmaphorum.com/news/fda-adcomm-turns-down-fibrogen-azs-roxadustat-for-ckd-anaemia/
FDA staffers defend Aduhelm approval in JAMA editorialThree FDA figures at the centre of the fallout over the approval Biogen and Eisai’s Alzheimer’s disease therapy Share XFDA staffers defend Aduhelm approval in JAMA editorialhttps://pharmaphorum.com/news/fda-staffers-defend-aduhelm-approval-in-jama-editorial/
FDA adds warning of rare neurological side effect to J&J COVID jabThe FDA has added a new warning on the Johnson & Johnson COVID-19 vaccine, saying the shot has Share XFDA adds warning of rare neurological side effect to J&J COVID jabhttps://pharmaphorum.com/news/fda-adds-warning-of-rare-neurological-side-effect-to-jj-covid-jab/
Bayer’s finerenone gets FDA nod for diabetic kidney diseaseBayer’s big investment in time and money on the development of finerenone for chronic kidney disease (CKD) in Share XBayer’s finerenone gets FDA nod for diabetic kidney diseasehttps://pharmaphorum.com/news/bayers-finerenone-gets-fda-nod-for-diabetic-kidney-disease/
Aduhelm approval controversy dials up as FDA seeks probeIn another twist to the Aduhelm approval tale, FDA’s Janet Woodcock has called for an independent investigation into Share XAduhelm approval controversy dials up as FDA seeks probehttps://pharmaphorum.com/news/aduhelm-approval-controversy-dials-up-as-fda-seeks-probe/
