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 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
Breast cancer drug buying time for terminal women amid push for PBS subsidy
20 February 2022 - Alison Day was given just months to live after being diagnosed with stage four terminal breast cancer ...
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 ...
Posted by Michael Wonder on 17 Feb 2022
Hospitals charge double for drugs - specialty pharmacies more affordable
16 February 2022 - As hospitals and physicians charge more for drugs they acquire and administer to generate higher payments, ...
Posted by Michael Wonder on 17 Feb 2022
Dr. Robert Califf returns as FDA's Commissioner
17 February 2022 - The Stakeholder Engagement Staff is pleased to announce the swearing in of Dr. Robert Califf this afternoon, ...
Posted by Michael Wonder on 17 Feb 2022
Agios wins FDA approval for pill to treat rare blood disease
17 February 2022 - The Cambridge company’s CEO says it has the potential to become a blockbuster drug. ...