Blog
RSS FeedPosted by Michael Wonder on 20 Dec 2018
ADMA Biologics provides regulatory update on Bivigam PAS submissions
19 December 2018 - FDA issues complete response letter for drug substance, approves supplement for drug product. ...
Posted by Michael Wonder on 04 Dec 2018
FDA promotes the development and adoption of innovations that can ensure the continued safety of the U.S. blood supply
4 December 2018 - Today the U.S. FDA updated a draft guidance entitled, “Bacterial Risk Control Strategies for Blood Collection Establishments ...
Posted by Michael Wonder on 27 Sep 2018
Aronora's new blood clot treatment receives FDA fast track designation
26 September 2018 - Enzyme that selectively targets blood clots has received FDA fast track designation, allowing for expedited clinical development. ...
Posted by Michael Wonder on 07 Sep 2018
FDA approves Grifols new GamaSTAN (immunoglobulin [human]) to treat patients exposed to hepatitis A and measles
4 September 2018 - New formulation is manufactured using Grifols' sophisticated caprylate chromatography process according to the highest quality and safety ...
Posted by Michael Wonder on 30 Aug 2018
Bayer receives US approval for modern haemophilia A treatment Jivi with a step-wise prophylaxis dosing regimen
30 August 2018 - Jivi’s extended half-life allows for twice-weekly initial dosing / May be adjusted to every five days and ...
Posted by Michael Wonder on 27 Jul 2018
ADMA Biologics receives PDUFA date for Bivigam regulatory submission
26 July 2018 - Prior approval supplement to amend the biologics license application for Bivigam is supported by data and documentation ...
Posted by Michael Wonder on 21 Jun 2018
Shire announces FDA approval for label expansion of Cinryze (C1 esterase inhibitor [human]) for prevention of attacks in paediatric hereditary angioedema patients
21 June 2018 - Shire is the only drug developer to complete a paediatric study for the prophylactic treatment of hereditary ...
Posted by Michael Wonder on 01 Jun 2018
Idelvion newly approved 3,500 IU vial to provide convenience to patients using larger volumes
31 May 2018 - New vial option delivers on CSL Behring’s promise to enhance current treatments and provide more alternatives to ...
Posted by Michael Wonder on 24 May 2018
FDA accepts supplemental biologics license application and grants priority review for prophylactic and paediatric use for Bio Products Laboratory's Coagadex (coagulation factor X, human) for treatment of hereditary factor X deficiency
23 May 2018 - FDA previously granted Coagadex orphan drug designation for the treatment of hereditary factor X deficiency. ...
Posted by Michael Wonder on 17 Apr 2018
FDA approves Vonvendi [von Willebrand factor (recombinant)] for peri-operative management of bleeding in adult patients with von Willebrand disease
17 April 2018 - Expanded use for Vonvendi – the first and only purified recombinant von Willebrand factor – builds on ...
Posted by Michael Wonder on 18 Mar 2018
FDA approves Hizentra (immune globulin subcutaneous [human] 20% liquid) for the treatment of patients with chronic inflammatory demyelinating polyneuropathy
16 March 2018 - First and only subcutaneous immunoglobulin approved for the treatment of CIDP based on the largest controlled clinical ...
Posted by Michael Wonder on 28 Feb 2018
Novo Nordisk files for regulatory approval of long-acting factor VIII (N8-GP) in the US and the EU for treatment of haemophilia A
28 February 2018 - Novo Nordisk today announced the submission of a biologics license applications to the US FDA and ...
Posted by Michael Wonder on 16 Feb 2018
Shire announces FDA acceptance of application for Cinryze (C1 esterase inhibitor [human]) for paediatric hereditary angioedema use
15 February 2018 - If approved, Cinryze will be the first and only C1-INH therapy indicated to help prevent HAE attacks ...
Posted by Michael Wonder on 10 Feb 2018
Grifols HyperRAB (rabies immune globulin [human]) 300 IU/mL receives FDA approval to treat patients exposed to rabies virus infection
6 February 2018 - Reduced volume of medication offers potential for fewer injections for patients. ...
Posted by Michael Wonder on 29 Nov 2017
Pharming submits supplemental biologics license application to FDA for Ruconest for prophylaxis of hereditary angioedema attacks
27 November 2017 - Submission based on positive results from two clinical trials. ...