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RSS FeedPosted by Michael Wonder on 20 Sep 2018
Pfizer granted FDA breakthrough therapy designation for 20 valent pneumococcal conjugate vaccine for the prevention of invasive disease and pneumonia in adults aged 18 years ands older
20 September 2018 - Breakthrough therapy designation designed by FDA to expedite the development and review of drugs and vaccines which ...
Posted by Michael Wonder on 20 Jul 2018
Sellas receives fast track designation from FDA for galinpepimut-S for the treatment of patients with multiple myeloma
20 July 2018 - Sellas Life Sciences today announced that the U.S. FDA has granted fast track designation to the Company’s ...
Posted by Michael Wonder on 14 Jun 2018
FDA grants priority review to Merck’s supplemental biologics license application for Gardasil 9 in women and men ages 27 to 45 for the prevention of certain HPV-related cancers and diseases
13 June 2018 - Merck today announced that the U.S. FDA has accepted for review a new supplemental biologics license application ...
Posted by Michael Wonder on 05 May 2018
FDA grants PaxVax fast track designation for its Chikungunya vaccine
4 May 2018 - There are no licensed vaccines for chikungunya prevention and no specific treatments. ...
Posted by Michael Wonder on 23 Apr 2018
Pfizer granted FDA breakthrough therapy designation for Trumenba (meningococcal Group B vaccine) for the prevention of invasive meningococcal B disease in children aged 1 to 9 years
23 April 2018 - Pfizer today announced that Trumenba (meningococcal Group B vaccine) received breakthrough therapy designation from the U.S. FDA ...
Posted 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 ...