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 23 Nov 2021
Seqirus announces U.S. FDA approval for multi-dose vial presentation of first ever adjuvanted, cell based pandemic influenza vaccine
23 November 2021 - The FDA has granted approval of multi-dose vial presentation for Audenz to help protect individuals six months ...
Posted by Michael Wonder on 23 Nov 2021
Isofol Medical receives FDA fast track designation for arfolitixorin in advanced colorectal cancer
23 November 2021 - Isofol Medical announced today that the U.S. FDA has granted fast track designation for the development ...
Posted by Michael Wonder on 23 Nov 2021
Prilenia receives fast track designation for pridopidine for the treatment of Huntington’s disease
17 November 2021 - Prilenia Therapeutics today announced that the U.S. FDA has granted Fast Track designation to pridopidine for ...
Posted by Michael Wonder on 23 Nov 2021
Update on regulatory review of aducanumab in the European Union
17 November 2021 - Biogen and Eisai announced today an update on the on-going review of the marketing authorisation application ...
Posted by Michael Wonder on 23 Nov 2021
Aadi Bioscience announces FDA approval of its first product Fyarro for patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumour
23 November 2021 - Fyarro is the first and only approved therapy for adults for the treatment of malignant PEComa, an ...
Posted by Michael Wonder on 22 Nov 2021
Deciphera receives European Commission approval of Qinlock for the treatment of fourth-line gastro-intestinal stromal tumour
22 November 2021 - Qinlock significantly reduced the risk of disease progression or death by 85% and showed clinically meaningful overall ...
Posted by Michael Wonder on 22 Nov 2021
European Commission approves Roche’s Gavreto (pralsetinib) for the treatment of adults with RET fusion-positive advanced non-small cell lung cancer
19 November 2021 - Gavreto is the first and only precision medicine approved in the EU for first-line treatment of people ...
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 ...