Drug News

Added 47 minutes ago Drug news

EMA validates MAA for Exparel for post surgical analgesia.-Pacira Pharma

Pacira BioSciences, Inc. announced that the company’s Marketing Authorization Application (MAA) for Exparel (bupivacaine liposome injectable suspension) for postsurgical analgesia...

Added 47 minutes ago Drug news

Brinavess refiled with FDA for recent onset atrial fibrillation.- Correvio Pharma

Correvio Pharma has resubmitted a New Drug Application (NDA) to the US FDA seeking approval for Brinavess (vernakalant hydrochloride, IV),...

Added 47 minutes ago Drug news

European Commission approves Doptelet for treatment of severe thrombocytopenia .- Dova Pharma

Dova Pharmaceuticals, Inc announced that the European Commission (EC) has granted marketing authorization for Doptelet (avatrombopag) for the treatment of...

Added 47 minutes ago Drug news

EMA validates MAA for Puldysa for the treatment of respiratory dysfunction in patients with Duchenne muscular dystrophy.- Santhera

Santhera Pharmaceuticals announces that the European Medicines Agency (EMA) has validated its marketing authorization application (MAA) for Puldysa (idebenone) in...

Added 47 minutes ago Drug news

Zejula sNDA submitted to FDA for ovarian, fallopian tube, or primary peritoneal cancer.- Tesaro

Tesaro has submitted a supplemental New Drug Application (sNDA) to the FDA for Zejula (niraparib). The application was granted priority...

Added 2 days ago Drug news

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

Santhera Pharmaceuticals announces that the UK's Medicines and Healthcare products Regulatory Agency (MHRA) has renewed for a further year the...

Added 2 days ago Drug news

New iclaprim data were presented at the American Society For Microbiology (ASM) Microbe 2019 meeting. Motif Bio

Motif Bio plc reported that new iclaprim data were presented at the American Society For Microbiology (ASM) Microbe 2019 meeting...

Added 1 day ago Drug news

Opdivo in CHECKMATE 459 trial versus sorafenib in hepatocellular carcinoma fails to achieve statistical significance for overall survival.- BMS

Bristol-Myers Squibb Company announced topline results from CheckMate -459, a randomized Phase III study evaluating Opdivo (nivolumab) versus sorafenib as...

Added 1 day ago Drug news

FDA lifts partial hold on CANOVA study of Venclexta to treat multiple myeloma.- AbbVie

AbbVie announced that the FDA has lifted the partial clinical hold placed on CANOVA (M13-494), a Phase III trial evaluating...

Added 2 days ago Drug news

FDA accepts sBLA for Baxdela to treat adult patients with community-acquired bacterial pneumonia .- Melinta Therapeutics

Melinta Therapeutics, Inc has announced the FDA has accepted a supplemental New Drug Application (sNDA) for Baxdela (delafloxacin) for priority...

Search all news articles