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RSS FeedPosted by Michael Wonder on 05 Aug 2015
FDA accepts Amgen's biologics license application for LDL cholesterol-lowering medication evolocumab
Amgen today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Amgen's Biologics License Application (BLA) for evolocumab for the treatment ...
Posted by Michael Wonder on 05 Aug 2015
ARIAD’s AP26113 receives FDA breakthrough therapy designation for ALK+ non small-cell lung cancer resistant to crizotinib
Ariad Pharmaceuticals today announced that its investigational cancer medicine, AP26113, has received Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the ...
Posted by Michael Wonder on 05 Aug 2015
FDA blueprint for helping children with rare diseases
The U.S. Congress and the Food and Drug Administration have long focused on bringing new therapies to patients with rare ...
Posted by Michael Wonder on 05 Aug 2015
Takeda’s investigational, oral proteasome inhibitor ixazomib citrate granted breakthrough therapy designation by U.S. FDA for relapsed or refractory systemic light-chain amyloidosis
Takeda Pharmaceutical Company Limited today announced that the U.S. Food & Drug Administration (FDA) has granted Breakthrough Therapy status to the ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves new antibacterial drug Zerbaxa
The U.S. Food and Drug Administration today approved Zerbaxa (ceftolozane/tazobactam), a new antibacterial drug product, to treat adults with complicated ...
Posted by Michael Wonder on 05 Aug 2015
U.S. FDA Commissioner Margaret Hamburg to step down
Dr. Margaret Hamburg, who as commissioner of the U.S. Food and Drug Administration (FDA) for almost six years has overseen ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Breo Ellipta for the treatment of adults with asthma in the US
GlaxoSmithKline plc. and Theravance, Inc. today announced that the US Food and Drug Administration (FDA) has approved Breo Ellipta (fluticasone furoate/vilanterol [FF/VI]) for the ...
Posted by Michael Wonder on 05 Aug 2015
Vertex receives U.S. Food and Drug Administration approval of Kalydeco (ivacaftor) for children with cystic fibrosis ages 2 to 5 who have specific mutations in the CFTR gene
Vertex Pharmaceuticals Incorporated today announced that the U.S. Food and Drug Administration (FDA) approved Kalydeco for use in children ages 2 to 5 ...
Posted by Michael Wonder on 05 Aug 2015
Breakthrough status for BI's Pradaxa antidote
The US Food and Drug Administration has granted breakthrough therapy designation to Boehringer Ingelheim’s antidote to its blockbuster bloodthinner Pradaxa. ...
Posted by Michael Wonder on 05 Aug 2015
ResMed shares slump on shock heart failure trial result
ResMed's shock result of its clinical trial, which put a group of patients at increased risk of dying and, in turn, ...
Posted by Michael Wonder on 05 Aug 2015
Medicure announces approval of expanded dosing time for Aggrastat
Medicure Inc., a specialty pharmaceutical company, is pleased to announce that the United States Food and Drug Administration (FDA) has ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Movantik (naloxegol) tablets C-II for the treatment of opioid-induced constipation in adult patients with chronic non-cancer pain
AstraZeneca today announced that the US Food and Drug Administration (FDA) approved Movantik (naloxegol) tablets C-II as the first once-daily oral ...
Posted by Michael Wonder on 05 Aug 2015
And then there were five
There are, broadly speaking, four ways to fight cancer. You can cut a tumour out, with surgery. Or you can try ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Novartis drug Odomzo (sonidegib) for locally advanced basal cell carcinoma (laBCC), a form of skin cancer
Novartis today announced the US Food and Drug Administration (FDA) has approved Odomzo (sonidegib, formerly LDE225) 200 mg capsules for the ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Anacor Pharmaceuticals' Kerydin (tavaborole) 5% topical solution for the treatment of onychomycosis of the toenails
Anacor Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application for Kerydin (tavaborole) 5% ...