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RSS FeedPosted by Michael Wonder on 10 May 2024
SN Bioscience receives FDA fast track designation for small cell lung cancer
9 May 2024 - SN Bioscience announced on 7 May that the FDA has granted fast track designation for small cell ...
Posted by Michael Wonder on 05 Dec 2023
Osteal Therapeutics’ VT-X7 receives FDA’s breakthrough therapy designation for the treatment of periprosthetic joint infection of the hip and knee
5 December 2023 - The US FDA granted breakthrough therapy designation for VT-X7, Osteal Therapeutics’ investigational drug therapy for periprosthetic joint ...
Posted by Michael Wonder on 13 Jul 2023
Dr. Reddy’s proposed rituximab biosimilar application accepted for review by US FDA, EMA and MHRA
12 July 2023 - Following dossier submission in April 2023, the regulatory agencies have now accepted the dossier for review. ...
Posted by Michael Wonder on 20 Feb 2023
Azafaros receives additional regulatory designations for AZ-3102 from FDA, EMA and MHRA
20 February 2023 - Azafaros today announced its progress in on-going interactions with health authorities regarding its lead asset, AZ-3102. ...
Posted by Michael Wonder on 27 Oct 2021
FDA collaborates with Health Canada and UK’s MHRA to foster good machine learning practice
27 October 2021 - Today, the U.S. FDA, Health Canada and the United Kingdom’s MHRA jointly issued the “Good Machine Learning ...
Posted by Michael Wonder on 04 Sep 2021
GSK’s shingles vaccine Shingrix gains UK license
2 September 2021 - GlaxoSmithKline's Shingrix has been licensed in the UK for the prevention of shingles in adults aged ...
Posted by Michael Wonder on 22 Jun 2021
Australia-Canada-Singapore-Switzerland-United Kingdom (Access) Consortium
22 June 2021 - The TGA is a member of the Access consortium along with Health Canada, Health Sciences Authority of ...
Posted by Michael Wonder on 20 May 2021
EMA, MHRA to review Vertex' Kaftrio for children with cystic fibrosis
20 May 2021 - The EMA and the MHRA have validated Vertex' applications to expand the scope of its cystic ...
Posted by Michael Wonder on 20 May 2021
NICE turns down Janssen's Erleada
20 May 2021 - NICE has published draft guidance rejecting Janssen's Erleada (apalutamide) with androgen deprivation therapy for treating prostate ...
Posted by Michael Wonder on 19 Nov 2020
NICE recommends another medicine for patients with multiple myeloma
18 November 2020 - Recommended for listing in the Cancer Drugs Fund. ...
Posted by Michael Wonder on 05 Nov 2020
Sobi launch Doptelet (avatrombopag) in Europe
4 November 2020 - Sobi today announced the commercial launch of Doptelet (avatrombopag) in Europe, with the United Kingdom as ...
Posted by Michael Wonder on 09 Oct 2020
MHRA to join Project Orbis
8 October 2020 - The UK is set to join the US FDA's Project Orbis at the start of next ...
Posted by Michael Wonder on 08 Jun 2020
NICE publishes appraisal consultation for isatuximab in combination with pomalidomide and dexamethasone for treating patients with relapsed and refractory multiple myeloma
4 June 2020 - The appraisal committee has considered the evidence submitted by the company and the views of non-company consultees ...
Posted by Michael Wonder on 04 May 2020
AstraZeneca to make Oxford vaccine as COVID-19 race heats up
30 April 2020 - AstraZeneca agreed to make an experimental coronavirus vaccine developed by Oxford University researchers as the race ...
Posted by Michael Wonder on 28 Apr 2020
In race for a coronavirus vaccine, an Oxford group leaps ahead
27 April 2020 - As scientists at the Jenner Institute prepare for mass clinical trials, new tests show their vaccine to ...