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RSS FeedPosted by Michael Wonder on 26 May 2017
Health Canada grants approval for Ocaliva (obeticholic acid) for the treatment of patients with primary biliary cholangitis
25 May 2017 - Ocaliva represents the first new treatment option in over 20 years for primary biliary cholangitis, an ...
Posted by Michael Wonder on 25 May 2017
Full green light for Biogen’s MS drug Fampyra
24 May 2017 - Biogen’s Fampyra has been granted a standard approval by European regulators on the back of late-stage ...
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
European Commission grants marketing authorisation for Zebinix (eslicarbazepine acetate) as once daily monotherapy in adults with newly diagnosed partial-onset epilepsy
23 May 2017 - Bial and Eisai today announce that the EMA has approved Zebinix (eslicarbazepine acetate) for use as a ...
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
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
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 20 May 2017
Highlights from the CHMP 15-18 May 2017 meeting
19 May 2017 - Eleven medicines recommended for approval, including one advanced therapy medicine ...
Posted by Michael Wonder on 20 May 2017
Sanofi receives CHMP recommendation for approval of insulin lispro biosimilar
19 May 2017 - Positive opinion based on a clinical development program involving over 1,000 people with type 1 or ...
Posted by Michael Wonder on 20 May 2017
Merck receives CHMP positive opinion recommending approval of Isentress (raltegravir) 600 mg in the European Union
19 May 2017 - Merck today announced that the CHMP of the EMA has adopted a positive opinion recommending approval of ...
Posted by Michael Wonder on 20 May 2017
Novartis receives positive CHMP opinion for first-line use of Zykadia in ALK-positive advanced non-small cell lung cancer
19 May 2017 - Phase III trial, first-line treatment with Zykadia resulted in improved progression-free survival over standard of care chemotherapy ...
Posted by Michael Wonder on 20 May 2017
How did Vertex win an FDA approval without running a clinical trial?
19 May 2017 - Vertex Pharmaceuticals scored a minor coup this week when the Food and Drug Administration signed off ...
Posted by Michael Wonder on 20 May 2017
CHMP recommends Veltassa for the treatment of hyperkalaemia in the EU
19 May 2017 - Opinion includes treatment of patients who develop hyperkalaemia while on RAAS inhibitors. ...
Posted by Michael Wonder on 20 May 2017
Brodalumab, a novel biologic for people with moderate-to-severe psoriasis, receives positive opinion from European CHMP
18 May 2017 - LEO Pharma today announced that it received a positive opinion from the European CHMP recommending marketing authorisation ...
Posted by Michael Wonder on 20 May 2017
CO.DON: decisive step towards European expansion
18 May 2017 - Positive opinion from relevant committee for EU approval of articular cartilage product ...