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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 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 ...
Posted by Michael Wonder on 17 Dec 2021
Recommendations made by the PBAC - November 2021
17 December 2021 - The recommendations from the November 2021 PBAC meeting are now available. ...
Posted by Michael Wonder on 16 Dec 2021
ICER publishes final evidence report and policy recommendations on tezepelumab for severe asthma
16 December 2021 - Independent appraisal committee found that evidence is adequate to demonstrate a net health benefit of tezepelumab ...
Posted by Michael Wonder on 16 Dec 2021
Why the big questions about drug prices are rarely asked: it’s hard to do
16 December 2021 - Public debate over legislation to allow Medicare to negotiate the price of drugs has been dominated ...
Posted by Michael Wonder on 16 Dec 2021
NICE recommend venetoclax and azacitidine for patients with aggressive blood cancer
16 December 2021 - Venetoclax is an oral once daily treatment, which blocks the action of the B-cell lymphoma-2 protein, ...
Posted by Michael Wonder on 16 Dec 2021
EMA issues advice on use of Paxlovid (PF-07321332 and ritonavir) for the treatment of COVID-19
16 December 2021 - Rolling review starts in parallel ...