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 28 Oct 2021
EMA nod for excessive daytime sleepiness med Ozawade
28 October 2021 - The EMA has approved Bioprojet’s Ozawade (pitolisant) for the treatment of excessive daytime sleepiness associated with ...
Posted by Michael Wonder on 28 Oct 2021
Repurposing of authorised medicines: pilot to support not for profit organisations and academia
28 October 2021 - EMA and the Heads of Medicines Agencies are launching a pilot project to support the repurposing ...
Posted by Michael Wonder on 28 Oct 2021
Vulnerable House Democrats warn not to drop drug pricing from package
27 October 2021 - Vulnerable House Democrats are urging leadership not to drop or water down a provision to allow ...
Posted by Michael Wonder on 28 Oct 2021
Booster doses of COVID-19 vaccines recommended for people aged 18 and over
28 October 2021 - The Australian Technical Advisory Group on Immunisation (ATAGI) have recommended a booster dose of COVID-19 vaccine for ...
Posted by Michael Wonder on 28 Oct 2021
Breakthrough Ortek-ECD technology enables dentists to detect cavities often not seen by X-rays
26 October 2021 - Ortek announced today the widespread availability of its ECD device, which provides dental professionals a new diagnostic ...
Posted by Michael Wonder on 28 Oct 2021
MY01 continuous compartmental pressure monitor granted breakthrough device designation from the FDA
28 October 2021 - MY01 receives their first-ever breakthrough device designation by the FDA in October, joining a select list of ...
Posted by Michael Wonder on 28 Oct 2021
Be careful who you sue: CytoDyn knowingly submitted an incomplete drug application to FDA, new documents show
28 October 2021 - CytoDyn and its CEO Nader Pourhassan have known the company’s long delayed HIV drug was in ...
Posted by Michael Wonder on 28 Oct 2021
COVID-19 vaccine weekly safety report (28 October 2021)
28 October 2021 - To 24 October, the TGA has received 235 reports which have been assessed as likely to be ...
Posted by Michael Wonder on 27 Oct 2021
Audrey Ashman’s bone treatment for rare genetic disease known as XLH denied government subsidy
24 October 2021 - Audrey Ashman loves to ballet dance and plays with her brothers — but she needs a special ...
Posted by Michael Wonder on 27 Oct 2021
Novavax files for authorisation of its COVID-19 vaccine in the United Kingdom
27 October 2021 - Filing marks first protein based COVID-19 vaccine submitted to MHRA for authorisation. ...
Posted by Michael Wonder on 27 Oct 2021
Moderna announces Swissmedic authorises booster dose of Moderna’s COVID-19 vaccine
26 October 2021 - Authorisation granted for particularly vulnerable individuals 12 years of age and older. ...
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 27 Oct 2021
FDA, NIH and 15 private organisations join forces to increase effective gene therapies for rare diseases
27 October 2021 - The U.S. FDA, the National Institutes of Health, 10 pharmaceutical companies and five non-profit organisations have partnered ...
Posted by Michael Wonder on 27 Oct 2021
Vertex's supplement to a new drug aubmission for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in patients ages 6-11 accepted for priority review by Health Canada
27 October 2021 - Vertex Pharmaceuticals today announced that its supplement to a new drug submission for Trikafta (elexacaftor/tezacaftor/ivacaftor and ...
Posted by Michael Wonder on 27 Oct 2021
Novartis receives priority review by US FDA and filing acceptance by EMA for Kymriah to treat patients with relapsed or refractory follicular lymphoma
27 October 2021 - Filings supported by pivotal ELARA trial, where treatment with Kymriah showed robust response rates and remarkable safety ...