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 Feb 2022
Minimally invasive epilepsy treatment EASEE receives FDA breakthrough device designation
21 February 2022 - Precisis has received breakthrough device designation from the U.S. FDA for its EASEE brain stimulator. FDA’s ...
Posted by Michael Wonder on 28 Feb 2022
Biohaven and Pfizer receive positive CHMP opinion for migraine treatment
25 February 2022 - Biohaven Pharmaceutical and Pfizer today announced that the CHMP of the EMA adopted a positive opinion for ...
Posted by Michael Wonder on 28 Feb 2022
New treatment for Australians with rare blood disease
28 February 2022 - Australians with paroxysmal nocturnal haemoglobinuria—a condition that produces defective blood cells—will have access to a new treatment ...
Posted by Michael Wonder on 27 Feb 2022
Update on Tyvaso DPI new drug application
24 February 2022 - MannKind Corporation was informed that the U.S. FDA issued an information request to United Therapeutics Corporation ...
Posted by Michael Wonder on 27 Feb 2022
NHS treats first sickle cell disease patients with life changing drug
24 February 2022 - One of the first patients to access a ground-breaking treatment for sickle cell disease on the ...
Posted by Michael Wonder on 27 Feb 2022
Health Canada authorises Medicago COVID-19 vaccine for adults 18 to 64 years of age
25 February 2022 - Today, Health Canada authorised Medicago's Covifenz COVID-19 vaccine for the prevention of COVID-19 in adults 18 to ...
Posted by Michael Wonder on 26 Feb 2022
Highlights from CHMP 21-24 February 2022 meeting
25 February 2022 - EMA’s CHMP recommended thirteen medicines for approval at its February 2022 meeting. ...
Posted by Michael Wonder on 26 Feb 2022
Reata Pharmaceuticals receives complete response letter from the FDA for bardoxolone for the treatment of patients with chronic kidney disease caused by Alport syndrome
25 February 2022 - Reata Pharmaceuticals today announced that the U.S. FDA has issued a complete response letter regarding the ...
Posted by Michael Wonder on 26 Feb 2022
COVID-19 vaccines: individual patient data should be submitted to the European Medicines Agency
24 February 2022 - An interesting letter to the Editor of the BMJ from the Head of Drug Assessment at ...
Posted by Michael Wonder on 26 Feb 2022
Landmark PBS listing for Australians with leukaemia
25 February 2022 - From 1 March 2022, Australians with acute myeloid leukaemia will have access to a new treatment option ...
Posted by Michael Wonder on 26 Feb 2022
FDA accepts for review Pfizer’s supplemental application for Abrilada (adalimumab-afzb) interchangeability
25 February 2022 - Pfizer today announced that the U.S. FDA has accepted for review the prior approval supplement to the ...
Posted by Michael Wonder on 25 Feb 2022
Assessment of public opinion on transparency at the US Food and Drug Administration
18 February 2022 - Historically, the US FDA has considered much of the oversight of clinical trials, interactions with companies, and ...
Posted by Michael Wonder on 25 Feb 2022
New medicine for rare type of eye cancer
25 February 2022 - EMA has recommended granting a marketing authorisation in the European Union (EU) for Kimmtrak (tebentafusp), a monotherapy ...
Posted by Michael Wonder on 25 Feb 2022
NICE draft guidance recommends tucatinib for advanced breast cancer
25 February 2022 - Taken as two 150 mg tablets twice daily together with anti-cancer medicines trastuzumab and capecitabine, tucatinib ...
Posted by Michael Wonder on 25 Feb 2022
PBAC recommendation for molnupiravir (Lagevrio)
25 February 2022 - The PBAC undertook an expedited consideration of a sponsor submission (MSD) to add molnupiravir (Lagevrio) to the ...