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RSS FeedPosted by Michael Wonder on 19 Dec 2017
60° Pharmaceuticals submits new drug application to US FDA for anti-malarial drug tafenoquine
18 December 2017 - 60P will continue global regulatory strategy and pursue additional dossier submissions. ...
Posted by Michael Wonder on 19 Dec 2017
Novartis multiple sclerosis therapy fingolimod granted FDA breakthrough therapy designation for paediatric multiple sclerosis
18 December 2017 - In a pivotal Phase III study, oral fingolimod significantly reduced relapses by 82% in a paediatric patient ...
Posted by Michael Wonder on 19 Dec 2017
Stealth BioTherapeutics granted fast track designation for elamipretide for the treatment of Leber’s hereditary optic neuropathy
18 December 2017 - Stealth BioTherapeutics today announced that the U.S. FDA has granted fast track designation for its lead candidate, ...
Posted by Michael Wonder on 18 Dec 2017
FDA accepts biologics license application for fremanezumab with priority review for prevention of migraine and grants fast track designation for cluster headache development program
18 December 2017 - Teva anticipates launching anti-CGRP product in the U.S. for the prevention of migraine in 2018. ...
Posted by Michael Wonder on 18 Dec 2017
US FDA accepts regulatory submission for Tagrisso in first-line EGFR-mutated non-small cell lung cancer
18 December 2017 - Tagrisso granted priority review. ...
Posted by Michael Wonder on 17 Dec 2017
WTX101 granted fast track designation by the U.S. FDA for the treatment of Wilson disease
14 December 2017 - Wilson Therapeutics today announced that the U.S. FDA has granted WTX101 fast track designation for the treatment ...
Posted by Michael Wonder on 17 Dec 2017
US FDA grants fast track designation to Renova Therapeutics’ RT-100 AC6 gene transfer for the treatment of heart failure
14 December 2107 - FLOURISH Phase 3 clinical trial in patients with heart failure and reduced ejection fraction to begin ...
Posted by Michael Wonder on 15 Dec 2017
FDA targets insulin for increased competition to lower prices
16 December 2017 - Prices of the diabetes medicine have risen 270%. ...
Posted by Michael Wonder on 15 Dec 2017
Pfizer announces FDA approval of Xeljanz (tofacitinib) and Xeljanz XR for the treatment of active psoriatic arthritis
14 December 2017 - Xeljanz/Xeljanz XR, the first oral JAK inhibitor in the U.S.for adults with moderate to severe rheumatoid arthritis, ...
Posted by Michael Wonder on 15 Dec 2017
Statement from FDA Commissioner on new FDA efforts to support more efficient development of targeted therapies
15 December 2017 - In recent years, the medical community has experienced a shift in the way health care is ...
Posted by Michael Wonder on 15 Dec 2017
Amicus Therapeutics submits new drug application to U.S. FDA for migalastat for treatment of Fabry Disease
14 December 2017 - Amicus Therapeutics submitted a new drug application to the U.S. FDA to request approval of the ...
Posted by Michael Wonder on 14 Dec 2017
New steps to facilitate beneficial medical device innovation
14 December 2017 - In recent days, the FDA has committed to several new policies that will modernise the agency’s approach ...
Posted by Michael Wonder on 14 Dec 2017
Months after approval, breakthrough cancer drug given to just five patients
14 December 2017 - No Medicare coverage, one-by-one rulings by private insurers. ...
Posted by Michael Wonder on 14 Dec 2017
Bumper crop of new drugs fails to lift big pharma R&D returns
14 December 2017 - It is shaping up to be a bumper year for drug approvals, with U.S. officials clearing twice ...
Posted by Michael Wonder on 14 Dec 2017
FDA approves new Pfizer biosimilar
13 December 2017 - Pfizer-developed biosimilar medicine Ixifi (infliximab-qbtx) receives FDA approval for all eligible indications. ...