Blog
RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
Posted by Michael Wonder on 04 Aug 2021
FDA regulation and approval of medical devices: 1976-2020
3 August 2021 - US law generally requires testing of high-risk medical devices prior to approval, as well as pre-market evaluation ...
Posted by Michael Wonder on 04 Aug 2021
FDA grants breakthrough device designation status for Hancock Jaffe's VenoValve
3 August 2021 - VenoValve is a potential treatment for approximately 2.4 million U.S. patients that suffer from severe chronic venous ...
Posted by Michael Wonder on 04 Aug 2021
Abbott receives FDA clearance for its imaging technology using artificial intelligence for vessels in the heart
3 August 2021 - Ultreon 1.0 software, the first-of-its-kind imaging software, merges optical coherence tomography with the power of automation using ...
Posted by Michael Wonder on 04 Aug 2021
Regulating digital health apps needs user-centered reform
3 August 2021 - When people seek health information, they expect what they get to be reliable and accurate. ...
Posted by Michael Wonder on 04 Aug 2021
MHRA approves first immunotherapy treatment for mesothelioma
3 August 2021 - The MHRA has approved the combination of nivolumab plus ipilimumab for the first-line treatment of adult ...
Posted by Michael Wonder on 03 Aug 2021
Moderna receives FDA fast track designation for respiratory syncytial virus vaccine (mRNA-1345)
3 August 2021 - Moderna today announced that the U.S. FDA has granted fast track designation for mRNA-1345, its investigational ...
Posted by Michael Wonder on 03 Aug 2021
Bristol Myers Squibb statement on Istodax (romidepsin) relapsed/refractory peripheral T-cell lymphoma U.S. indication
3 August 2021 - In 2011, Celgene, now a wholly owned subsidiary of Bristol Myers Squibb, received accelerated approval by the ...
Posted by Michael Wonder on 03 Aug 2021
FDA approves new Berinert (C1 esterase inhibitor, human (intravenous)) administration kit for increased patient convenience
3 August 2021 - CSL Behring has received U.S. FDA approval for its supplemental request for co-packaging of a convenience ...
Posted by Michael Wonder on 03 Aug 2021
Complete response letter received from FDA for treosulfan
3 August 2021 - Medexus Pharmaceuticals and medac announced today that medac has received a complete response letter from the ...
Posted by Michael Wonder on 03 Aug 2021
Marinus Pharmaceuticals submits new drug application to FDA for ganaxolone for the treatment of seizures associated with CDKL5 deficiency disorder
3 August 2021 - Marinus Pharmaceuticals today announced the submission of a new drug application to the FDA for the ...
Posted by Michael Wonder on 03 Aug 2021
Don’t want a vaccine? Be prepared to pay more for insurance.
2 August 2021 - America’s Covid-19 vaccination rate is at around 60 percent, for ages twelve and up. ...
Posted by Michael Wonder on 03 Aug 2021
The FDA finally gets moving on Pfizer
2 August 2021 - The agency will now ‘sprint’ to grant full vaccine approval. ...
Posted by Michael Wonder on 03 Aug 2021
US FDA grants priority review to Roche’s Tecentriq as adjuvant treatment for certain people with early non-small cell lung cancer
3 August 2021 - Application is being reviewed under the US FDA’s Real-Time Oncology Review pilot programme. ...
Posted by Michael Wonder on 03 Aug 2021
DoH publishes revised agenda for Nov 2021 PBAC meeting
3 August 2021 - One week on and we are already up to version 3. ...
Posted by Michael Wonder on 03 Aug 2021
GSK files for licensure of MMR vaccine in the US
2 August 2021 - GSK seeks US approval of Priorix vaccine licensed in more than 100 countries. ...