BioCentury | Sep 17, 2019
Regulation

FDA’s international drug review pilot could simplify cancer trials, get drugs to patients faster

...surgery or radiation. Health Canada granted the combination conditional approval, and Australian Therapeutic Goods Administration (TGA...
...approval. FDA started the project this spring, with a monthly joint teleconference with regulators from TGA...
...of even years before an important medicine would be submitted to regulatory agencies such as TGA...
BioCentury | Apr 17, 2018
Politics & Policy

Australia to evaluate Lilly's Lartruvo under new provisional pathway

...Australia's Therapeutic Goods Administration (TGA) said soft tissue sarcoma drug Lartruvo olaratumab from Eli Lilly and...
BioCentury | Sep 16, 2016
Politics & Policy

Australia planning new approval pathways

...new pathways is an expedited approval pathway that allows for accelerated assessment of new medicines. TGA...
...plans to implement a provisional approval pathway that would allow approval based on surrogate endpoints. TGA...
...the Australian market up to four months sooner than with its current framework, TGA said. TGA...
BioCentury | Sep 5, 2016
Company News

Merck sales and marketing update

...patients may choose to not permit brand substitution. In July, Australia’s Therapeutic Goods Administration ( TGA...
BioCentury | Aug 23, 2016
Company News

Australia's PBAC says Enbrel biosimilar can be substituted

...and is marketed in Europe as Benepali . In July, Australia's Therapeutic Goods Administration ( TGA...
BioCentury | Feb 16, 2015
Clinical News

Deoxycholic acid regulatory update

...Kythera submitted a regulatory application to Australia’s Therapeutic Goods Administration ( TGA ) for ATX-101 to...
BioCentury | Dec 15, 2014
Clinical News

Iclusig ponatinib regulatory update

...Australia’s Therapeutic Goods Administration ( TGA ) approved Iclusig ponatinib from Ariad to treat chronic myelogenous...
BioCentury | Oct 20, 2014
Clinical News

Jetrea ocriplasmin regulatory update

...ThromboGenics said Australia's Therapeutic Goods Administration ( TGA ) approved Jetrea ocriplasmin to treat vitreomacular traction...
BioCentury | Sep 1, 2014
Clinical News

Prosigna Breast Cancer Prognostic Gene Signature Assay regulatory update

...Australia’s Therapeutic Goods Administration ( TGA ) approved NanoString’s Prosigna Breast Cancer Prognostic Gene Signature Assay...
BioCentury | Jul 28, 2014
Clinical News

RFVIIIFc regulatory update

...Idec disclosed in its results for 2Q14 that in June Australia's Therapeutic Goods Administration ( TGA...
...Idec disclosed in its results for 2Q14 that in June Australia's Therapeutic Goods Administration ( TGA...
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