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 Aug 2021
European Commission approves Rinvoq (upadacitinib) as first JAK inhibitor in the European Union for the treatment of both adults and adolescents with moderate to severe atopic dermatitis
24 August 2021 - Approval supported by data from one of the largest registrational Phase 3 programs in atopic dermatitis evaluating ...
Posted by Michael Wonder on 24 Aug 2021
UCB announces European Commission approval of Bimzelx (bimekizumab) for the treatment of adults with moderate to severe plaque psoriasis
24 August 2021 - The approval in the European Union represents the first marketing authorisation for UCB’s new psoriasis treatment worldwide. ...
Posted by Michael Wonder on 24 Aug 2021
FDA, drug makers propose new pilots aimed at speeding rare disease drugs, as part of user fee update
23 August 2021 - The FDA and the drug industry have jointly agreed to create several new pilot programs aimed ...
Posted by Michael Wonder on 24 Aug 2021
Clovis Oncology announces availability of and reimbursement for Rubraca (rucaparib) tablets for women with relapsed ovarian cancer in Switzerland
24 August 2021 - Rubraca is commercially available in Germany, United Kingdom, Italy, Spain, France, Netherlands, United States of America and ...
Posted by Michael Wonder on 24 Aug 2021
Method paper: IQWiG puts draft version 6.1 up for discussion
23 August 2021 - The IQWiG has presented the draft for the next version of its General Methods. ...
Posted by Michael Wonder on 24 Aug 2021
Optimising the data available via Health Canada’s clinical information portal
23 August 2021 - Through its Public Release of Clinical Information initiative, Health Canada has provided public access to a vast ...
Posted by Michael Wonder on 24 Aug 2021
FDA grants breakthrough device designation for renal failure
23 August 2021 - ImpediMed is pleased to announce SOZO has received FDA breakthrough device designation for a proposed indication ...
Posted by Michael Wonder on 24 Aug 2021
Limited access to 'lifesaving' cystic fibrosis drug Trikafta under Pharmaceutical Benefits Scheme
24 August 2021 - A mother whose son lives with cystic fibrosis says young people are dying as they wait for ...
Posted by Michael Wonder on 23 Aug 2021
Pfizer-BioNTech COVID-19 vaccine Comirnaty receives full U.S. FDA approval for individuals 16 years and older
23 August 2021 - Comirnaty is the first COVID-19 vaccine to be granted FDA approval. ...
Posted by Michael Wonder on 23 Aug 2021
Cara Therapeutics and Vifor Pharma announce U.S. FDA approval of Korsuva (difelikefalin) injection for the treatment of moderate to severe pruritus in hemodialysis patients
23 August 2021 - Promotional launch of Korsuva injection in the U.S. is expected in Q1 2022, with reimbursement in H1 ...
Posted by Michael Wonder on 23 Aug 2021
Europe has its first Lucentis biosimilar, Samsung Bioepis’ Byooviz
23 August 2021 - Novartis and Roche’s big-selling eye drug Lucentis has its first biosimilar competitor in Europe, after the ...
Posted by Michael Wonder on 23 Aug 2021
U.S. Food and Drug Administration accepts for priority review Bristol Myers Squibb’s application for Orencia (abatacept) for the prevention of acute graft versus host disease
23 August 2021 - The sBLA is supported by the Phase 2 ABA2 trial evaluating Orencia in adults and children to ...
Posted by Michael Wonder on 23 Aug 2021
Estimands, estimators and estimates
23 August 2021 - The primary goal of most randomised clinical trials is to draw conclusions about the effect of a ...
Posted by Michael Wonder on 23 Aug 2021
FDA approves first COVID-19 vaccine
23 August 2021 - Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. ...
Posted by Michael Wonder on 23 Aug 2021
Axsome Therapeutics provides update on the new drug application for AXS-05 for the treatment of major depressive disorder
23 August 2021 - Axsome Therapeutics today announced that the U.S. FDA informed the Company in a teleconference on August 20, ...