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RSS FeedPosted by Michael Wonder on 21 Feb 2022
Apple iPhone game changing new health feature cleared by FDA, coming in weeks
20 February 2022 - A new app is coming this spring which will be game changing for diabetes care. ...
Posted by Michael Wonder on 21 Feb 2022
U.S. FDA approves FoundationOne CDx as a companion diagnostic for Keytruda (pembrolizumab) to identify patients with microsatellite instability-high solid tumours
21 February 2022 - Foundation Medicine’s tissue-based comprehensive genomic profiling test is now the first and only FDA approved companion diagnostic ...
Posted by Michael Wonder on 21 Feb 2022
Allarity Therapeutics receives refusal to file letters from U.S. FDA
18 February 2022 - Allarity intends to seek guidance from the FDA on how to further advance dovitinib and its ...
Posted by Michael Wonder on 20 Feb 2022
BioNTech plans to make vaccines in shipping containers
19 February 2022 - These standardised factories could be quickly scaled up to expand capacity worldwide. ...
Posted by Michael Wonder on 19 Feb 2022
FDA eyes second COVID-19 booster shot
19 February 2022 - The agency has begun reviewing data that could lead to clearing a second booster dose of ...
Posted by Michael Wonder on 19 Feb 2022
FDA’s Califf shares priority list with agency staff
18 February 2022 - Combatting misinformation about science and responding to the ongoing COVID-19 pandemic are the top priorities for ...
Posted by Michael Wonder on 19 Feb 2022
How digital therapeutics platforms are revolutionising health care delivery
17 February 2022 - With enormous advances in digital health innovation, we are quickly moving into an age where software platforms ...
Posted by Michael Wonder on 19 Feb 2022
BeiGene announces approval for Brukinsa (zanubrutinib) by Swissmedic for treatment of adult patients with Waldenström’s macroglobulinaemia
17 February 2022 - With this approval, Brukinsa is now approved in 44 markets as BeiGene continues to advance its global ...
Posted by Michael Wonder on 18 Feb 2022
OSE Immunotherapeutics is pleased to announce that Veloxis Pharmaceuticals, its partner in transplantation, has obtained FDA fast track designation for CD28 antagonist VEL-101/FR104
17 February 2022 - OSE Immunotherapeutics today announced that Veloxis Pharmaceuticals has obtained fast track designation from the U.S. FDA for ...
Posted by Michael Wonder on 18 Feb 2022
Regulatory decisions diverge over aducanumab for Alzheimer’s disease
19 February 2022 - The EMA refused marketing authorisation for aducanumab (Aduhelm), a monoclonal antibody targeted at amyloid β, in December ...
Posted by Michael Wonder on 18 Feb 2022
Immune-Onc Therapeutics receives FDA fast track designation for IO-202, the first anti-LILRB4 myeloid checkpoint inhibitor, for the treatment of relapsed or refractory acute myeloid leukaemia
17 February 2022 - Immune-Onc Therapeutics today announced that the U.S. FDA has granted fast track designation for IO-202, a first ...
Posted by Michael Wonder on 18 Feb 2022
Agios announces FDA approval of Pyrukynd (mitapivat) as first disease-modifying therapy for haemolytic anaemia in adults with pyruvate kinase deficiency
17 February 2022 - Company to provide robust patient access programs, including $0 copays and free medication for eligible patients. ...
Posted by Michael Wonder on 18 Feb 2022
Sandoz launches generic lenalidomide in 19 countries across Europe, expanding access to essential oncology medicine
18 February 2022 - Cost savings from Lenalidomide Sandoz can expand treatment options for patients with haemato-oncology conditions. ...
Posted by Michael Wonder on 18 Feb 2022
Dizal Pharmaceutical receives U.S. FDA fast track designation for DZD4205 (golidocitinib) for the treatment of refractory or relapsed peripheral T-cell lymphoma
18 February 2022 - Fast track designation proves Dizal's world leading capability of developing potential first-in-class and much needed therapy to ...
Posted by Michael Wonder on 18 Feb 2022
European Commission approves Tepmetko (tepotinib) for patients with advanced NSCLC with METex14 skipping alterations
18 February 2022 - Approval is based on Phase II results from VISION, the largest interventional study to date of patients ...