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RSS FeedPosted by Michael Wonder on 21 Dec 2017
The Regulatory Accountability Act of 2017 — implications for FDA regulation and public health
20 December 2017 - In the past year, federal health policy has been characterized by pervasive uncertainty, but a consistent theme ...
Posted by Michael Wonder on 21 Dec 2017
TherapeuticsMD announces FDA acceptance of new drug application and Prescription Drug User Fee Act Date for TX-004HR
20 December 2017 - PDUFA target action date of 29 May 2018. ...
Posted by Michael Wonder on 21 Dec 2017
Bristol-Myers Squibb receives FDA approval for Opdivo (nivolumab) as adjuvant therapy in patients with completely resected melanoma with lymph node involvement or metastatic disease
20 December 2017 - Opdivo, the first and only anti-PD-1 immune checkpoint inhibitor approved for adjuvant treatment of melanoma, is indicated ...
Posted by Michael Wonder on 20 Dec 2017
U.S. Food and Drug Administration approves prior approval supplement for commercial launch of Portola Pharmaceuticals’ novel oral anti-coagulant Bevyxxa (betrixaban)
19 December 2017 - Bevyxxa available to patients in January 2018. ...
Posted by Michael Wonder on 20 Dec 2017
Exelixis announces U.S. FDA approval of Cabometyx (cabozantinib) tablets for previously untreated advanced renal cell carcinoma
19 February 2017 - Approval expands indication and comes well in advance of PDUFA date of 15 February 2018. ...
Posted by Michael Wonder on 20 Dec 2017
U.S. FDA approves Pfizer’s Bosulif (bosutinib) for the treatment of patients with newly-diagnosed PH+ chronic myelogenous leukaemia (CML)
19 December 2017 - Pfizer's third U.S. haematology approval in five months. ...
Posted by Michael Wonder on 19 Dec 2017
Ovid Therapeutics announces OV101 granted fast track designation by U.S. FDA for treatment of Angelman syndrome
19 December 2017 - Ovid Therapeutics today announced that the U.S. FDA has granted fast track designation to OV101 for the ...
Posted by Michael Wonder on 19 Dec 2017
Aerie Pharmaceuticals announces U.S. FDA approval of Rhopressa (netarsudil ophthalmic solution) 0.02% for the lowering of elevated intra-ocular pressure in patients with open-angle glaucoma or ocular hypertension
18 December 2017 - Product approved ahead of the Scheduled PDUFA date of 28 February 2018. ...
Posted 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 15 Dec 2017
FDA targets insulin for increased competition to lower prices
16 December 2017 - Prices of the diabetes medicine have risen 270%. ...