Blog
RSS FeedPosted by Michael Wonder on 28 Apr 2025
Telix provides regulatory update on TLX101-CDx
28 April 2028 - Telix Pharmaceuticals today announces that it has received a complete response letter from the US FDA ...
Posted by Michael Wonder on 24 Apr 2025
Latest update on US FDA BLA for Novavax's COVID-19 vaccine
23 April 2025 - We believe that our biologics license application is approvable based on conversations with the US FDA, ...
Posted by Michael Wonder on 09 Apr 2025
FDA approves nivolumab with ipilimumab for unresectable or metastatic MSI-H or dMMR colorectal cancer
8 April 2025 - Today, the FDA approved nivolumab (Opdivo, Bristol Myers Squibb Company) with ipilimumab (Yervoy, Bristol Myers Squibb ...
Posted by Michael Wonder on 12 Mar 2025
Sydnexis announces FDA acceptance of new drug application and PDUFA date for SYD-101 for the treatment of progression of paediatric myopia
11 March 2025 - Sydnexis today announced that the US FDA has accepted its new drug application for SYD-101 and ...
Posted by Michael Wonder on 10 Mar 2025
US FDA approves Celltrion's Omlyclo (omalizumab-igec) as the first and only biosimilar with interchangeability designation referencing Xolair
9 March 2025 - Regulatory approval for interchangeability was supported by positive Phase 3 data demonstrating comparable efficacy and safety profile ...
Posted by Michael Wonder on 05 Mar 2025
FDA accepts supplemental biologics license application for Roche’s Gazyva/Gazyvaro for the treatment of lupus nephritis
5 March 2025 - The filing application is based on data from the Phase 3 REGENCY study, where Gazyva/Gazyvaro showed superiority ...
Posted by Michael Wonder on 05 Mar 2025
Tevimbra approved in US for first-line treatment of advanced oesophageal squamous cell carcinoma in combination with chemotherapy
4 March 2025 - New indication based on results from a global Phase 3 trial demonstrating significantly improved overall survival ...
Posted by Michael Wonder on 06 Feb 2025
Supernus announces FDA approval of Onapgo (apomorphine hydrochloride) for Parkinson’s disease
4 February 2025 - Supernus Pharmaceuticals announced today that the US FDA approved Onapgo (apomorphine hydrochloride) injection, formerly known as SPN-830, ...
Posted by Michael Wonder on 06 Jul 2024
Four decades of orphan drugs and priorities for the future
6 July 2024 - The Orphan Drug Act was enacted in the United States in 1983 in response to growing awareness ...
Posted by Michael Wonder on 23 Jun 2024
Top FDA official Peter Marks overruled staff, review team to approve Sarepta gene therapy
20 June 2024 - For a third time, Sarepta Therapeutics has convinced a top FDA official to overrule the prevailing ...
Posted by Michael Wonder on 09 Nov 2023
FDA approves first treatment for patients with rare inherited blood clotting disorder
9 November 2023 - Today, the US FDA approved Adzynma, the first recombinant protein product indicated for prophylactic or on demand ...
Posted by Michael Wonder on 17 Oct 2021
FDA needs a competitiveness czar
15 October 2021 - The FDA needs a Deputy Commissioner for Regulatory Competitiveness. ...
Posted by Michael Wonder on 08 Jan 2021
FDA statement on following the authorised dosing schedules for COVID-19 vaccines
4 January 2021 - Two different mRNA vaccines have now shown remarkable effectiveness of about 95% in preventing COVID-19 disease ...
Posted by Michael Wonder on 03 Nov 2020
Is it time for the FDA to be independent?
3 November 2020 - Public health experts and lay observers alike have expressed concerns that, under political pressure, the FDA ...
Posted by Michael Wonder on 26 Feb 2019
'Wacky' drug price system keeps costs high for patients paying for prescriptions, FDA chief says
26 February 2019 - "The sick people are helping to subsidise the healthy people. That's not how insurance is supposed to ...