Blog
RSS FeedPosted by Michael Wonder on 26 Feb 2018
Statement from FDA Commissioner on FDA’s ongoing efforts to help improve effectiveness of influenza vaccines
26 February 2018 - The current influenza season has been especially difficult, causing widespread illness that has affected all fifty ...
Posted by Michael Wonder on 08 Feb 2018
GSK’s meningitis B vaccine Bexsero receives breakthrough therapy designation from US FDA for prevention of invasive meningococcal disease in children 2-10 years of age
7 February 2018 - GlaxoSmithKline today announced that it has received breakthrough therapy designation from the U.S. FDA for its meningitis ...
Posted by Michael Wonder on 30 Jan 2018
Takeda's Zika vaccine gets U.S. FDA's 'fast track' status
30 January 2018 - Japan’s Takeda Pharmaceutical Co Ltd said on Monday the U.S. FDA had granted ‘fast track’ status to ...
Posted by Michael Wonder on 13 Jan 2018
GSK receives FDA approval for expanded indication for Fluarix Quadrivalent (influenza vaccine) for persons 6 months and older
11 January 2018 - GSK announced today it has received approval from the US FDA's Center for Biologics Evaluation and Research ...
Posted by Michael Wonder on 10 Nov 2017
Dynavax announces FDA approval of Heplisav-B for prevention of hepatitis B in adults
9 November 2017 - First and only two-dose vaccine in United States for prevention of hepatitis B in adults. ...
Posted by Michael Wonder on 26 Oct 2017
New shingles vaccine endorsed over competitor by expert panel, a boost for GSK
25 October 2017 - The expert panel that helps guide U.S. vaccination policy has voted to give a preferential recommendation ...
Posted by Michael Wonder on 23 Oct 2017
GSK wins U.S. shingles vaccine approval, UK nod for gene therapy
23 October 2017 - GlaxoSmithKline has won U.S. approval for a new and improved shingles vaccine, the second of three ...
Posted by Michael Wonder on 21 Oct 2017
Shingrix approved in the US for prevention of shingles in adults aged 50 and over
20 October 2017 - Pooled clinical trial results showed > 90 percent efficacy across all age groups. ...
Posted by Michael Wonder on 18 Sep 2017
Seqirus receives FDA approval of Afluria Quadrivalent (influenza vaccine) for people five years of age and older in the U.S.
14 September 2017 - Expanded Afluria Quadrivalent age indication offers protection against four influenza virus strains for people five years of ...
Posted by Michael Wonder on 04 Aug 2017
Dynavax provides U.S. regulatory update on Heplisav following FDA Advisory Committee meeting
3 August 2017 - Dynavax Technologies Corporation today announced that the U.S. FDA has requested more detailed information about the company's ...
Posted by Michael Wonder on 27 Jul 2017
Sequoia Sciences receives FDA fast track designation for vaccine for urinary tract infections caused by multidrug-resistant bacteria
26 July 2017 - Non-antibiotic treatment approach may reduce the development of antibiotic resistance and promote antibiotic stewardship. ...
Posted by Michael Wonder on 25 Jul 2017
Valneva receives FDA fast track designation for its Lyme disease vaccine candidate VLA15
24 July 2017 - The company aims to accelerate VLA15’s development and plans to initiate a Phase II trial in ...
Posted by Michael Wonder on 05 Apr 2017
Vaccines and the Trump Administration
4 April 2017 - Writing recently in the New York Times, infectious disease physician Peter Hotez warned: “It’s looking as ...
Posted by Michael Wonder on 16 Mar 2017
GSK announces US regulatory submission seeking expanded indication for Fluarix Quadrivalent (influenza vaccine) for infants 6 months and older
15 March 2017 - GSK today announced the submission of a supplemental biologics license application to the U.S. FDA for ...
Posted by Michael Wonder on 02 Mar 2017
Dynavax announces FDA acceptance for review of its complete response to November 2016 CRL and PDUFA action date for Heplisav-B
28 February 2017 - Dynavax Technologies announced today that the U.S. FDA has accepted for review Dynavax's responses to the complete ...