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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
Gilead submits biologics license application to U.S. Food and Drug Administration for bulevirtide, an investigational treatment for people living with chronic hepatitis delta
19 November 2021 - If approved, bulevirtide will be the first treatment option for adult patients in the U. S. with ...
Posted by Michael Wonder on 22 Nov 2021
Intarcia Therapeutics takes one last shot at FDA approval
22 November 2021 - Its diabetes treatment twice rejected, the company is in the midst of a rarely used appeal process, ...
Posted by Michael Wonder on 22 Nov 2021
Vertex announces reimbursement agreement in Spain for Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor to treat people with cystic fibrosis 12 years and older with at least one F508del mutation in the CFTR gene
19 November 2021 - With this reimbursement agreement approximately 700 people with cystic fibrosis now have access to a CFTR ...
Posted by Michael Wonder on 22 Nov 2021
Bristol Myers Squibb announces new PDUFA date for mavacamten
19 November 2021 - Bristol Myers Squibb today announced that the U.S. FDA has extended the review of the new ...
Posted by Michael Wonder on 22 Nov 2021
CRISPR Therapeutics announces FDA regenerative medicine advanced therapy designation granted to CTX110 for the treatment of relapsed or refractory CD19+ B-cell malignancies
22 November 2021 - CRISPR Therapeutics today announced that the U.S. FDA granted regenerative medicine advanced therapy designation to CTX110, ...
Posted by Michael Wonder on 22 Nov 2021
Pear Therapeutics receives FDA breakthrough device designation for prescription digital therapeutic candidate to treat alcohol use disorder
22 November 2021 – Pear Therapeutics today announced that it has received breakthrough device designation from the U.S. FDA for ...
Posted by Michael Wonder on 22 Nov 2021
bluebird bio Announces FDA priority review of biologics license application for beti-cel gene therapy for patients with β-thalassemia who require regular red blood cell transfusions
22 November 2021 - FDA set PDUFA date of 20 May 2022. ...
Posted by Michael Wonder on 22 Nov 2021
UK recognises Covaxin as valid COVID-19 vaccine for travel
21 November 2021 - Travellers vaccinated with Bharat Biotech’s Covaxin will now be able to enter the UK, as the ...
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. ...