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RSS FeedPosted by Michael Wonder on 11 Dec 2024
Delgocitinib approved to treat adult patients with moderate to severe chronic hand eczema
10 December 2024 - The MHRA has approved the medicine delgocitinib (Anzupgo) to treat moderate to severe chronic hand eczema in ...
Posted by Michael Wonder on 09 Oct 2024
Elafibranor approved as first medicine to treat adults with a rare liver disease known as primary biliary cholangitis
8 October 2024 - The MHRA has approved elafibranor (Iqirvo) to treat adult patients with a rare type of liver disease ...
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 09 Nov 2023
CASI Pharmaceuticals announces market approval of CNCT19 by China NMPA
8 November 2023 - CASI Pharmaceuticals is thrilled to announce a major milestone in its partnership with Juventas Cell Therapy. ...
Posted by Michael Wonder on 09 Nov 2023
MHRA authorises diabetes drug Mounjaro (tirzepatide) for weight management and weight loss
8 November 2023 - For the first time in the UK, obese patients and people who are overweight with weight-related health ...
Posted by Michael Wonder on 06 Sep 2022
NASWSI and Project Orbis - are they essentially the same?
7 September 2022 - We compare and contrast the two initiatives to bring new medicines to the market faster. ...
Posted by Michael Wonder on 27 Jul 2022
MS Health push for nurses to hand out abortion pills
27 July 2022 - Nurses and midwives would prescribe medical abortion pills under a push by the company that imports ...
Posted by Michael Wonder on 03 Mar 2022
If Medicare Part D redesign ever happens, it could lead to lower prescription drug prices
2 March 2022 - On 1 March, during the State of the Union address, President Biden continued to push for some ...
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 05 Jun 2021
Could big pharma actually lose this fight over drug prices? It's Biden's call.
3 June 2021 - More than 20 years ago, when I was the press secretary for then-Congressman Bernie Sanders, I rode ...
Posted by Michael Wonder on 30 Mar 2021
Terminal cancer patients denied new treatments due to slow TGA approval
31 March 2021 - Desperate cancer patients are begging Australia’s drugs regulator to save lives by speeding up approvals and cutting ...
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 ...