10,624 Results
Opdivo in CHECKMATE 459 trial versus sorafenib in hepatocellular carcinoma fails to achieve statistical significance for overall survival.- BMS
Added 20 hours ago
Bristol-Myers Squibb Company announced topline results from CheckMate -459, a randomized Phase III study evaluating Opdivo (nivolumab) versus sorafenib as...
FDA lifts partial hold on CANOVA study of Venclexta to treat multiple myeloma.- AbbVie
Added 20 hours ago
AbbVie announced that the FDA has lifted the partial clinical hold placed on CANOVA (M13-494), a Phase III trial evaluating...
UK's MHRA has renewed for a further year the Early Access to Medicines Scheme scientific opinion for idebenone for patients with Duchenne muscular dystrophy.- Santhera
Added 20 hours ago
Santhera Pharmaceuticals announces that the UK's Medicines and Healthcare products Regulatory Agency (MHRA) has renewed for a further year the...
New iclaprim data were presented at the American Society For Microbiology (ASM) Microbe 2019 meeting. Motif Bio
Added 20 hours ago
Motif Bio plc reported that new iclaprim data were presented at the American Society For Microbiology (ASM) Microbe 2019 meeting...
FDA accepts sBLA for Baxdela to treat adult patients with community-acquired bacterial pneumonia .- Melinta Therapeutics
Added 1 day ago
Melinta Therapeutics, Inc has announced the FDA has accepted a supplemental New Drug Application (sNDA) for Baxdela (delafloxacin) for priority...
EU approves Talzenna for HER2- breast cancer.- Pfizer
Added 1 day ago
Pfizer Inc. announced that the European Commission approved Talzenna (talazoparib), an oral poly (ADP-ribose) polymerase (PARP) inhibitor, as monotherapy for...
FDA approves sBLA for Dextenza to include the treatment of ocular inflammation following ophthalmic surgery.- Ocular Therapeutix.
Added 1 day ago
Ocular Therapeutix, Inc. announced the FDA approved a Supplemental New Drug Application (sNDA) for Dextenza to include the treatment of...
FDA approves Vyleesi to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.- AMAG Pharma
Added 1 day ago
AMAG Pharmaceuticals, Inc. announced that the FDA has approved Vyleesi (bremelanotide injection), a melanocortin receptor agonist, to treat acquired, generalized...
FDA approves Symdeko for use in children with cystic fibrosis who have two copies of the F508del-CFTR mutation or who at least one mutation in the CFTR gene.- Vertex
Added 2 days ago
Vertex Pharmaceuticals Incorporated announced the FDA approved Symdeko (tezacaftor/ivacaftor and ivacaftor) for use in children with cystic fibrosis ages 6...