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 19 May 2021
BioXcel Therapeutics announces FDA acceptance for filing of NDA for BXCL501 for the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II
19 May 2021 - FDA sets PDUFA action date for 5 January 2022. ...
Posted by Michael Wonder on 19 May 2021
BeiGene announces U.S. FDA acceptance and priority review of supplemental new drug application for Brukinsa (zanubrutinib) in marginal zone lymphoma
19 May 2021 - BeiGene today announced that the U.S. FDA has accepted a supplemental new drug application for Brukinsa ...
Posted by Michael Wonder on 19 May 2021
‘Use effective drugs in early multiple myeloma to prevent relapse’
19 May 2021 - Multiple myeloma patients suffer frequent recurrences, and treatment response rates and response durations plummet along with ...
Posted by Michael Wonder on 19 May 2021
Pfizer withdraws evidence submission for Staquis
19 May 2021 - NICE is unable to make a recommendation on the use of crisaborole for the treatment of people ...
Posted by Michael Wonder on 19 May 2021
FDA launches crowdsourcing challenge to solicit input on research questions to be addressed through FDA's oncologic clinical trial data
18 May 2021 - Today, the U.S. FDA's Oncology Center of Excellence launched the “Send Your Oncology Research Questions to ...
Posted by Michael Wonder on 19 May 2021
FDA: flexibility okay for gaps in gene therapy trials
18 May 2021 - The US FDA is not amenable to changing study outcome measures or sample sizes for gene therapy ...
Posted by Michael Wonder on 19 May 2021
Top FDA official says fully vaccinated people could need Covid booster shots within a year
18 May 2021 - COVID-19 booster shots could be needed for fully vaccinated people within a year, the FDA’s top ...
Posted by Michael Wonder on 19 May 2021
COVID-19 vaccines: In the rush for regulatory approval, do we need more data?
18 May 2021 - After rollout under emergency authorisation, manufacturers of COVID-19 vaccines now have their sights on regulatory approval. ...
Posted by Michael Wonder on 19 May 2021
NICE terminates yet another appraisal of a cancer medicine
19 May 2021 - This time it is for a new medicine for patients with multiple myeloma. ...
Posted by Michael Wonder on 18 May 2021
Essilor receives FDA breakthrough device designation for Essilor Stellest, its new generation of spectacle lens solutions in the fight against myopia
17 May 2021 - Essilor today announced that the U.S. FDA has granted breakthrough device designation to its Essilor Stellest spectacle ...
Posted by Michael Wonder on 18 May 2021
Northern Ireland faces ‘huge’ rise in generic medicine prices
18 May 2021 - Large increase likely after end of Brexit grace period, warns UUP head Simon Aiken. ...
Posted by Michael Wonder on 18 May 2021
Quebec announces intention to implement a biosimilar switching policy
18 May 2021 - Biosimilars Canada today congratulated the Government of Quebec and Minister of Health and Social Services Christian ...
Posted by Michael Wonder on 18 May 2021
Belgium seeks to encourage generic drugs with new prescription reimbursement structure
18 May 2021 - The federal government has decided to increase the percentage by which generic drugs will be reimbursed, ...
Posted by Michael Wonder on 18 May 2021
Pharmaceutical company AbbVie inflated prices for two major drugs, House Oversight report says
18 May 2021 - The House Oversight and Reform Committee found that the company increased prices for Humira and Imbruvica. ...
Posted by Michael Wonder on 18 May 2021
Sandoz Canada congratulates the Quebec government on implementing a shift towards biosimilars
18 May 2021 - The shift announced by Quebec will follow a similar approach to policies introduced in British Columbia, Alberta ...