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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 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 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 13 Dec 2017
When can FDA 'Refuse to File' NDAs and BLAs? New draft guidance explains
12 December 2017 - When a new drug application or biologics license application is deemed incomplete by the US FDA, ...
Posted by Michael Wonder on 13 Dec 2017
Alnylam completes submission of new drug application to U.S. FDA for patisiran for the treatment of hereditary ATTR amyloidosis
12 December 2017 - Patisiran could become the first in a new class of medicines known as RNAi therapeutics. ...
Posted by Michael Wonder on 12 Dec 2017
Indivior announces NDA acceptance of RBP-7000 risperidone monthly depot
12 December 2017 - A novel sustained-release candidate for treatment of schizophrenia. ...
Posted by Michael Wonder on 12 Dec 2017
Bayer’s rivaroxaban submitted to U.S. FDA for approval in patients with coronary and/or peripheral artery disease
11 December 2017 - The rivaroxaban vascular dose, 2.5 mg twice daily plus aspirin 100 mg once daily, demonstrated a 24% ...
Posted by Michael Wonder on 12 Dec 2017
Regeneron announces FDA acceptance of sBLA filing for 12 week dosing of Eylea (aflibercept) injection for patients with wet AMD
11 December 2017 - Regeneron Pharmaceuticals today announced that the U.S. FDA has accepted for review the Company's supplemental biologics ...
Posted by Michael Wonder on 12 Dec 2017
SIGA Technologies announces FDA submission of its new drug application for oral TPOXX (tecovirimat) to treat smallpox
11 December 2017 - Company requests priority review of TPOXX new drug application. ...
Posted by Michael Wonder on 11 Dec 2017
Galcanezumab is the first of three investigational, non-opioid treatments in Lilly's pain portfolio
11 December 2017 - Eli Lilly announced today that the U.S.FDA has accepted a biologics license application to review galcanezumab ...
Posted by Michael Wonder on 08 Dec 2017
Concentric Analgesics receives FDA fast track designation for CA-008 for post-surgical pain
7 December 2017 - Novel pro-drug with unique mechanism of action takes on the opioid crisis. ...
Posted by Michael Wonder on 08 Dec 2017
Acorda resubmits new drug application for Inbrija (CVT-301, levodopa inhalation powder)
7 December 2017 - Acorda Therapeutics announced the resubmission of its new drug application for Inbrija to the U.S. FDA. ...
Posted by Michael Wonder on 06 Dec 2017
FDA accepts new drug application for buprenorphine sublingual spray from INSYS Therapeutics
6 December 2017 - Novel formulation of partial opioid offers potential benefits compared to current alternatives. ...
Posted by Michael Wonder on 04 Dec 2017
TherapeuticsMD announces resubmission of new drug application for TX-004HR
29 November 2017 - TherapeuticsMD announced today that it has resubmitted the new drug application for TX-004HR, the company’s investigational ...