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 Dec 2021
Novavax announces submission of new drug application in Japan for approval of COVID-19 vaccine
15 December 2021 - Takeda submits application for TAK-019/NVX-CoV2373, the first protein-based COVID-19 vaccine candidate for new drug application, to Japan's ...
Posted by Michael Wonder on 19 Dec 2021
Fist Assist Devices receives FDA “breakthrough device” designation for the world’s first wearable vein dilation device for ESRD patients
16 December 2021 - Indication for pre-surgical vein dilation use to promote AV fistula creation. ...
Posted by Michael Wonder on 19 Dec 2021
ATAGI update following weekly COVID-19 meeting (15 December 2021)
18 December 2021 - On Wednesday 15 December 2021 ATAGI reviewed the latest developments relating to COVID-19 and COVID-19 vaccine safety. ...
Posted by Michael Wonder on 18 Dec 2021
Chinese official a ‘hero’ after forcing US drug maker Biogen to cut cost of treatment for spinal disease with ‘gentle but firm’ approach
6 December 2021 - US pharmaceutical company reduces the price of a drug for a rare spinal disease after seven rounds ...
Posted by Michael Wonder on 18 Dec 2021
PHARMAC bundle deal life-giving for some cancer patients, but medics say NZ still 'playing catch up' for best treatments
16 December 2021 - About 100 patients with stage 3 lung cancer stand to gain extra years of life from ...
Posted by Michael Wonder on 18 Dec 2021
Pfizer and BioNTech submit supplemental biologics license application for U.S. FDA approval of Comirnaty in adolescents 12 through 15 years of age
16 December 2021 - Pfizer and BioNTech today announced they have submitted a supplemental biologics license application to the U.S. ...
Posted by Michael Wonder on 18 Dec 2021
bluebird bio announces FDA priority review of biologics license application for eli-cel gene therapy for cerebral adrenoleukodystrophy in patients without a matched sibling donor
17 December 2021 - If approved, eli-cel will be the first and only gene therapy for the treatment of cerebral adrenoleukodystrophy, ...
Posted by Michael Wonder on 18 Dec 2021
FDA approves drug to treat sickle cell disease in patients aged 4 up to 11 years
17 December 2021 - The FDA has granted accelerated approval for Oxbryta (voxelotor) tablets to treat sickle cell disease in paediatric ...
Posted by Michael Wonder on 18 Dec 2021
New treatment for sickle cell disease
17 December 2021 - EMA has recommended granting a marketing authorisation in the EU for Oxbryta (voxelotor) for the treatment of ...
Posted by Michael Wonder on 18 Dec 2021
Overall survival for oncology drugs approved for genomic indications
17 December 2021 - Drug approvals for genome-informed indications have been increasing in recent years, but it is unknown how many ...
Posted by Michael Wonder on 18 Dec 2021
Astellas and Seagen receive positive CHMP opinion for Padcev (enfortumab vedotin) in locally advanced or metastatic urothelial cancer
17 December 2021 - If approved, PADCEV would be the first medicine for patients in the EU who have received prior ...
Posted by Michael Wonder on 18 Dec 2021
Tepmetko (tepotinib) receives positive CHMP opinion for patients with advanced NSCLC with METex14 skipping alterations
17 December 2021 - Tepmetko is the first and only oral MET inhibitor to receive CHMP positive opinion in Europe ...
Posted by Michael Wonder on 18 Dec 2021
Tezspire (tezepelumab) approved in the US for severe asthma
17 December 2021 - Only biologic for severe asthma approved with no phenotype or biomarker limitations ...
Posted by Michael Wonder on 17 Dec 2021
FDA approves new treatment for myasthenia gravis
17 December 2021 - The U.S. Food and Drug Administration today approved Vyvgart (efgartigimod) for the treatment of generalized myasthenia gravis ...
Posted by Michael Wonder on 17 Dec 2021
Medicine agency recommends listing of life-saving drugs for Australian men with deadly forms of prostate cancer
17 December 2021 - Prostate Cancer Foundation of Australia has welcomed recommendations by Australia’s Pharmaceutical Benefits Advisory Committee to list ...