7 January 2019 - ADMA Biologics announces that the Company has submitted responses to the U.S. FDA complete response letter received ...
19 December 2018 - FDA issues complete response letter for drug substance, approves supplement for drug product. ...
4 December 2018 - Today the U.S. FDA updated a draft guidance entitled, “Bacterial Risk Control Strategies for Blood Collection Establishments ...
26 September 2018 - Enzyme that selectively targets blood clots has received FDA fast track designation, allowing for expedited clinical development. ...
4 September 2018 - New formulation is manufactured using Grifols' sophisticated caprylate chromatography process according to the highest quality and safety ...
30 August 2018 - Jivi’s extended half-life allows for twice-weekly initial dosing / May be adjusted to every five days and ...
26 July 2018 - Prior approval supplement to amend the biologics license application for Bivigam is supported by data and documentation ...
21 June 2018 - Shire is the only drug developer to complete a paediatric study for the prophylactic treatment of hereditary ...
31 May 2018 - New vial option delivers on CSL Behring’s promise to enhance current treatments and provide more alternatives to ...
23 May 2018 - FDA previously granted Coagadex orphan drug designation for the treatment of hereditary factor X deficiency. ...
17 April 2018 - Expanded use for Vonvendi – the first and only purified recombinant von Willebrand factor – builds on ...
16 March 2018 - First and only subcutaneous immunoglobulin approved for the treatment of CIDP based on the largest controlled clinical ...
28 February 2018 - Novo Nordisk today announced the submission of a biologics license applications to the US FDA and ...
15 February 2018 - If approved, Cinryze will be the first and only C1-INH therapy indicated to help prevent HAE attacks ...
6 February 2018 - Reduced volume of medication offers potential for fewer injections for patients. ...