BioCentury | Feb 3, 2014
Clinical News

NovoThirteen catridecacog regulatory update

...is approved in Canada as Tretten catridecacog; in the EU, Switzerland and Australia as NovoThirteen catridecacog...
...catridecacog; in the EU, Switzerland and Australia as NovoThirteen catridecacog; and in the U.S. as Tretten...
...Bristol-Myers Squibb Co. (NYSE:BMY), New York, N.Y. Product: NovoThirteen catridecacog ( Tretten ), recombinant coagulation Factor XIII A-subunit ( rFXIII...
BioCentury | Jan 13, 2014
Finance

Buyside View XXII: 'Grown up' means growth

...Hemophilia A U.S. Novo Nordisk A/S (CSE:NVO; NYSE:NVO)/Bristol-Myers Squibb Co. (NYSE:BMY) Tretten recombinant coagulation Factor XIII A-subunit (Tretten catridecacog, NovoThirteen...
BioCentury | Jan 6, 2014
Finance

4Q Stock Wrap-Up: All's well that ends well

...in adults and children Novo Nordisk A/S (CSE:NVO; NYSE:NVO)/Bristol-Myers Squibb Co. (NYSE:BMY) FDA approves Tretten recombinant coagulation Factor XIII A-subunit...
BioCentury | Jan 6, 2014
Clinical News

Tretten recombinant coagulation Factor XIII A-subunit regulatory update

...On Dec. 23, 2013, FDA approved a resubmitted BLA from Novo Nordisk for Tretten recombinant coagulation Factor XIII A-subunit to...
...approved in Canada as Tretten catridecacog and in the EU, Switzerland and Australia as NovoThirteen catridecacog...
...Denmark Bristol-Myers Squibb Co. (NYSE:BMY), New York, N.Y. Product: Tretten recombinant coagulation Factor XIII A-subunit ( NovoThirteen catridecacog) ( rFXIII...
BioCentury | Dec 24, 2013
Company News

FDA approves Novo product for congenital Factor XIII deficiency

...FDA approved a resubmitted BLA from Novo Nordisk A/S (CSE:NVO; NYSE:NVO) for Tretten cartridecacog to prevent...
...A-subunit is approved in Canada as Tretten and in the EU, Switzerland and Australia as NovoThirteen...
BioCentury | Nov 4, 2013
Finance

Calithera metabolizes

...disclosed that last month it resubmitted a BLA to FDA for NovoThirteen recombinant factor XIII (rFXIII...
BioCentury | Nov 1, 2013
Company News

Novo to start releasing clinical study reports

...disclosed that this month it resubmitted a BLA to FDA for recombinant factor XIII ( rFXIII...
BioCentury | Aug 12, 2013
Clinical News

rFXIII regulatory update

...received a second complete response letter from FDA for a BLA for recombinant factor XIII (rFXIII...
...Novo Nordisk A/S (CSE:NVO; NYSE:NVO), Bagsvaerd, Denmark Bristol-Myers Squibb Co. (NYSE:BMY), New York, N.Y. Product: rFXIII...
BioCentury | Aug 12, 2013
Finance

Signed and sealed

...June a second complete response letter from FDA for a BLA for recombinant factor XIII (rFXIII...
BioCentury | Aug 9, 2013
Financial News

Novo receives second CRL for rFXIII, reports 1H13 financials

...a second complete response letter from FDA for a BLA for recombinant factor XIII ( rFXIII...
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