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RSS FeedPosted by Michael Wonder on 26 May 2017
Novartis receives FDA approval for expanded use of Zykadia in first-line ALK-positive metastatic non-small cell lung cancer
26 May 2017 - In ALK-positive metastatic NSCLC patients, Zykadia median progression-free survival was 16.6 months, compared to 8.1 months with ...
Posted by Michael Wonder on 26 May 2017
CalciMedica receives fast-track designation for CM4620, a novel CRAC channel inhibitor to treat acute pancreatitis
24 May 2017 - Patient studies expected to begin in 2018. ...
Posted by Michael Wonder on 25 May 2017
FDA approves Merck’s Keytruda (pembrolizumab) for adult and pediatric patients with unresectable or metastatic, microsatellite instability-high or mismatch repair deficient cancer
23 May 2017 - Keytruda now approved for patients with MSI-H or mismatch repair deficient solid tumours that have progressed following ...
Posted by Michael Wonder on 24 May 2017
Accelerated approval and expensive drugs — a challenging combination
24 May 2017 - For serious or life-threatening disease, the FDA can approve drugs on the basis of surrogate end points ...
Posted by Michael Wonder on 24 May 2017
U.S. Food and Drug Administration accepts for priority review Bristol-Myers Squibb’s application for Opdivo (nivolumab) in previously treated hepatocellular carcinoma
24 May 2017 - Application is based on results from the Phase 1/2 CheckMate-040 trial. ...
Posted by Michael Wonder on 24 May 2017
Ultragenyx announces recombinant human beta-glucuronidase biologics license application and marketing authorisation application filed and accepted for review; FDA grants priority review status
23 May 2017 - Ultragenyx today announced that a biologics license application submitted to the U.S. FDA and a marketing ...
Posted by Michael Wonder on 24 May 2017
Plazomicin granted FDA breakthrough therapy designation
23 May 2017 - Breakthrough therapy designation supports the potential of plazomicin as a substantial improvement over existing therapies ...
Posted by Michael Wonder on 23 May 2017
FDA grants priority review to Merck’s supplemental biologics license application for Keytruda (pembrolizumab) for treatment of recurrent or advanced gastric or gastro-oesophageal junction adenocarcinoma
23 May 2017 - Data supporting application to be presented at 2017 ASCO Annual Meeting. ...
Posted by Michael Wonder on 23 May 2017
FDA approves first cancer treatment for any solid tumour with a specific genetic feature
23 May 2017 - The U.S. FDA today granted accelerated approval to a treatment for patients whose cancers have a ...
Posted by Michael Wonder on 23 May 2017
New FDA pathway to accelerate development of cell therapies
22 May 2017 - Four products have already qualified for the regenerative medicine advanced therapy designation that provides extra interactions with ...
Posted by Michael Wonder on 23 May 2017
Sanofi and Regeneron announce FDA approval of Kevzara (sarilumab) for the treatment of moderately to severely active rheumatoid arthritis in adult patients
22 May 2017 - Kevzara is now available to U.S. patients. ...
Posted by Michael Wonder on 22 May 2017
Drugs approved with limited data aren’t always well-tested later
19 May 2017 - New medicines that win U.S. marketing approval without conclusive evidence of their effectiveness aren't always proven ...
Posted by Michael Wonder on 22 May 2017
FDA approves first drug to specifically treat giant cell arteritis
22 May 2017 - The U.S. FDA today expanded the approved use of subcutaneous Actemra (tocilizumab) to treat adults with ...
Posted by Michael Wonder on 21 May 2017
Amgen submits biologics license application to the FDA for erenumab
18 May 2017 - Erenumab is an investigative treatment specifically designed to prevent migraine only molecule in late-stage development to ...
Posted by Michael Wonder on 20 May 2017
Janssen files suit in U.S. to block sale of Samsung Bioepis' Remicade copy
18 May 2017 - A unit of healthcare conglomerate Johnson & Johnson filed a lawsuit to block a copy of ...