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 24 Nov 2021
Califf, Biden’s pick to lead FDA, has millions invested in pharma and tech companies
23 November 2021 - Robert Califf, President Biden’s choice to lead the FDA, earned $2.7 million as an executive at ...
Posted by Michael Wonder on 24 Nov 2021
Semaglutide (Wegovy) stakeholder meeting outcome statement
24 November 2021 - The outcome statement for the semaglutide stakeholder meeting held on 26 August 2021 is now available. ...
Posted by Michael Wonder on 24 Nov 2021
FDA nomination slips after Biden admin fails to send papers to Congress
23 November 2021 - The delay means that Califf is now unlikely to get a confirmation hearing until mid-December at the ...
Posted by Michael Wonder on 24 Nov 2021
Swiss regulator approves Pfizer/BioNTech booster for 16 and up
23 November 2021 - Swissmedic has approved the extension of COVID-19 boosters for the Pfizer/BioNTech vaccine to all people aged 16 ...
Posted by Michael Wonder on 24 Nov 2021
Health Canada approves Keytruda (pembrolizumab) in combination with chemotherapy for the treatment of locally recurrent unresectable or metastatic triple negative breast cancer whose tumours express PD-L1 (CPS ≥10)
23 November 2021 - Conditional approval based on data from Phase 3 KEYNOTE-355 trial; introduces first breast cancer indication for ...
Posted by Michael Wonder on 24 Nov 2021
HAGAR GWave awarded FDA breakthrough device designation
23 November 2021 - Expediting development of GWave technology that may potentially improve the health and quality of life for millions ...
Posted by Michael Wonder on 24 Nov 2021
FDA approves first treatment for common type of post-transplant infection that is resistant to other drugs
23 November 2021 - Today, the U.S. FDA approved Livtencity (maribavir) as the first drug for treating adults and paediatric patients ...
Posted by Michael Wonder on 23 Nov 2021
Why is aducanumab priced at $56,000 per patient? Lessons for drug pricing reform.
20 November 2021 - Aducanumab’s price can inform the drug pricing policy debate because it responds to key features of ...
Posted by Michael Wonder on 23 Nov 2021
Medicare coverage of aducanumab — implications for state budgets
20 November 2021 - CMS is considering whether and under what circumstances Medicare will pay for aducanumab for Alzheimer’s disease. ...
Posted by Michael Wonder on 23 Nov 2021
The BBB’s threat to biosimilar drug development
23 November 2021 - In 2019, longtime pharmaceutical industry critic, Peter Bach, took to the Wall Street Journal to declare that ...
Posted by Michael Wonder on 23 Nov 2021
Use of confidence intervals in interpreting non-statistically significant results
23 November 2021 - The goal of much of medical research is to determine which of 2 or more therapeutic approaches ...
Posted by Michael Wonder on 23 Nov 2021
EMA receives application for marketing authorisation for Lagevrio (molnupiravir) for treating patients with COVID-19
23 November 2021 - EMA has started evaluating an application for marketing authorisation for the oral antiviral medicine Lagevrio (molnupiravir). ...
Posted by Michael Wonder on 23 Nov 2021
Amryt provides update on regulatory review process for Oleogel-S10
23 November 2021 - FDA PDUFA goal date extended by three months to 28 February 2022. ...
Posted by Michael Wonder on 23 Nov 2021
Seqirus announces U.S. FDA approval for multi-dose vial presentation of first ever adjuvanted, cell based pandemic influenza vaccine
23 November 2021 - The FDA has granted approval of multi-dose vial presentation for Audenz to help protect individuals six months ...
Posted by Michael Wonder on 23 Nov 2021
Isofol Medical receives FDA fast track designation for arfolitixorin in advanced colorectal cancer
23 November 2021 - Isofol Medical announced today that the U.S. FDA has granted fast track designation for the development ...