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 22 Nov 2021
EMA evaluating data on booster dose of COVID-19 Vaccine Janssen
22 November 2021 - EMA has started evaluating an application for the use of a booster dose of COVID-19 Vaccine ...
Posted by Michael Wonder on 22 Nov 2021
FDA grants breakthrough designation for early stage breast cancer detection blood test developed by Datar Cancer Genetics
19 November 2021 - TriNetra is a circulating tumour cell detection blood test which is able to identify early stage ...
Posted by Michael Wonder on 22 Nov 2021
Obseva announces U.S. FDA acceptance of new drug application for linzagolix
22 November 2021 - FDA accepts new drug application for linzagolix for the management of heavy menstrual bleeding associated with uterine ...
Posted by Michael Wonder on 22 Nov 2021
Pfizer to provide U.S. Government with 10 million treatments courses of investigational oral antiviral candidate to help combat COVID-19
18 November 2021 - If approved or authorised, Paxlovid (PF-07321332; ritonavir) would be the first oral anti-viral of its kind, a ...
Posted by Michael Wonder on 22 Nov 2021
TGA grants provisional determination to Grand Pacific for its COVID-19 protein-based subunit vaccine
22 November 2021 - The Therapeutic Goods Administration has granted provisional determination to Grand Pacific CRO (the Australian sponsor acting ...
Posted by Michael Wonder on 22 Nov 2021
New PBS listing helps Australians with rare genetic condition
21 November 2021 - From 1 December 2021, Australians with a rare and potentially deadly condition, hereditary angioedema, will be able ...
Posted by Michael Wonder on 21 Nov 2021
Moderna files for authorisation of its COVID-19 vaccine with Health Canada to include children ages 6-11 years
17 November 2021 - Submission based on Phase 2/3 study of SPIKEVAX in children ages 6 to 11. ...
Posted by Michael Wonder on 21 Nov 2021
Rare condition medication going on PBS
21 November 2021 - From next month a medication for a rare and potentially deadly genetic condition with be available ...
Posted by Michael Wonder on 20 Nov 2021
FDA grants Theradaptive breakthrough medical device designation
19 November 2021 - Theradaptive announced that the U.S. FDA has granted breakthrough medical device designation to its Osteo-Adapt SP Spinal ...
Posted by Michael Wonder on 20 Nov 2021
BioNTech receives FDA fast track designation for its FixVac candidate BNT111 in advanced melanoma
19 November 2021 - BioNTech today announced that the U.S. FDA granted fast track designation for BNT111, an investigational cancer ...
Posted by Michael Wonder on 20 Nov 2021
Pfizer's Xeljanz (tofacitinib) receives marketing authorisation in the European Union for the treatment of active ankylosing spondylitis
18 November 2021 - Pfizer announced today that the European Commission has approved Xeljanz (tofacitinib) 5 mg twice daily for the ...
Posted by Michael Wonder on 20 Nov 2021
Moderna announces FDA authorisation of booster dose of COVID-19 vaccine in the U.S. for adults 18 years and older
19 November 2021 - Authorisation includes the use of Moderna’s booster dose following primary vaccination with other authorised or approved ...
Posted by Michael Wonder on 20 Nov 2021
EMA issues advice on use of Lagevrio (molnupiravir) for the treatment of COVID-19
19 November 2021 - EMA’s CHMP has issued advice on the use of Lagevrio (molnupiravir, MK 4482) for the treatment of ...
Posted by Michael Wonder on 20 Nov 2021
MHRA authorises Vumerity for multiple sclerosis patients
19 November 2021 - The MHRA has granted marketing authorisation for diroximel fumarate as oral treatment for relapsing-remitting multiple sclerosis. ...
Posted by Michael Wonder on 20 Nov 2021
NICE recommends Inrebic for rare blood cancer
19 November 2021 - NICE have issued a final appraisal determination recommending the use of Inrebic (fedratinib) on the NHS for ...