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RSS FeedPosted 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% ...
Posted by Michael Wonder on 05 Aug 2015
Acorda Therapeutics announces notification of ANDA filing for Ampyra
Acorda Therapeutics, Inc. today announced receipt of a Paragraph IV Certification Notice Letter advising that Actavis Laboratories FL, Inc. submitted ...
Posted by Michael Wonder on 05 Aug 2015
U.S. Food and Drug Administration accepts supplemental biologics license application for Opdivo+Yervoy regimen in patients with previously untreated advanced melanoma
Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the supplemental ...
Posted by Michael Wonder on 05 Aug 2015
GW Pharmaceuticals announces Epidiolex receives fast track designation from FDA for the treatment of Dravet syndrome
GW Pharmaceuticals plc, a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, ...
Posted by Michael Wonder on 05 Aug 2015
Celldex's rindopepimut (Rintega) receives FDA breakthrough therapy designation for the treatment of adult patients with EGFRvIII-positive glioblastoma
Celldex Therapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted rindopepimut (Rintega) Breakthrough Therapy Designation for the treatment ...
Posted by Michael Wonder on 05 Aug 2015
Bristol-Myers Squibb announces acceptance of new drug application for investigational daclatasvir for FDA review for the treatment of hepatitis C genotype 3
Bristol-Myers Squibb Company announced today that the resubmitted new drug application (NDA) for daclatasvir, an investigational NS5A replication complex inhibitor, has ...