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 22 Dec 2020
Amgen submits sotorasib marketing authorisation application to the European Medicines Agency
22 December 2020 - Application is for patients with previously treated non-small cell lung cancer with the KRAS G12C mutation. ...
Posted by Michael Wonder on 22 Dec 2020
ViiV Healthcare announces the marketing authorisation of the first complete long-acting injectable HIV treatment in Europe
21 December 2020 - Marketing authorisation granted by European Commission for ViiV Healthcare’s Vocabria (cabotegravir injection and tablets) to be used ...
Posted by Michael Wonder on 22 Dec 2020
FDA approves Kineret (anakinra) for the treatment of deficiency of IL-1 receptor antagonist
22 December 2020 - DIRA is an ultra-rare, auto-inflammatory disease that typically presents in infancy and is characterised by life-threatening and ...
Posted by Michael Wonder on 22 Dec 2020
Ocular Therapeutix announces submission to the FDA of a supplemental new drug application for Dextenza (dexamethasone ophthalmic insert) for the treatment of ocular itching associated with allergic conjunctivitis
22 December 2020 - PDUFA target action date anticipated for October 2021. ...
Posted by Michael Wonder on 22 Dec 2020
EMA organises a second public meeting about the new COVID-19 vaccines
22 December 2020 - EMA will organise a second public meeting on 8 January 2021 to inform European citizens about ...
Posted by Michael Wonder on 22 Dec 2020
Shared decision making is an integral part of healthcare, says NICE
22 December 2020 - Shared decision making between patients and clinicians should be embedded throughout healthcare services, says NICE, in draft ...
Posted by Michael Wonder on 22 Dec 2020
Shionogi’s novel antibiotic, Fetcroja (cefiderocol), has been selected by UK’S NICE/NHSE&I as part of an antimicrobial subscription style reimbursement model
21 December 2020 - NICE and the National Health Service England and Improvement have recognised the potential of Shionogi’s innovative ...
Posted by Michael Wonder on 22 Dec 2020
FDA approves prosthetic implant for above the knee amputations
18 December 2020 - The U.S. FDA today approved the Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System, the ...
Posted by Michael Wonder on 22 Dec 2020
FDA approves paediatric indication for Xeomin (incobotulintoxinA) for the treatment of chronic sialorrhoea
21 December 2020 - Xeomin is the first and only neuromodulator approved in the U.S. to treat paediatric patients with chronic ...
Posted by Michael Wonder on 22 Dec 2020
FDA approves treatment for Ebola virus
21 December 2020 - The U.S. FDA approved Ebanga (Ansuvimab-zykl), a human monoclonal antibody, for the treatment for Zaire ebolavirus (Ebolavirus) ...
Posted by Michael Wonder on 22 Dec 2020
Jazz Pharmaceuticals announces initiation of biologics license application submission for JZP-458 for the treatment of acute lymphoblastic leukaemia or lymphoblastic lymphoma
21 December 2020 - Application to be reviewed under FDA's Oncology Center of Excellence Real-Time Oncology Review pilot program. ...
Posted by Michael Wonder on 21 Dec 2020
The FDA grants IO Biotech breakthrough therapy designation for IO102 and IO103 in combination with anti-PD-1 in unresectable/metastatic melanoma
15 December 2020 - IO Biotech today announced that the U.S. FDA has granted breakthrough therapy designation for a combination ...
Posted by Michael Wonder on 21 Dec 2020
Price disclosure 2021 April cycle outcomes summary
21 December 2020 - The summary of price disclosure price reductions for the 2021 April Cycle has now been published. ...
Posted by Michael Wonder on 21 Dec 2020
Janssen initiates rolling submission of a biologics license application to U.S. FDA for BCMA CAR-T therapy ciltacabtagene autoleucel (cilta-cel) for the treatment of relapsed and/or refractory multiple myeloma
21 December 2020 - Janssen announced today the initiation of a rolling submission of its biologics license application to the ...
Posted by Michael Wonder on 21 Dec 2020
Sesen Bio submits completed biologics license application to the FDA for Vicineum and has requested priority review
21 December 2020 - BLA supported by strong Phase 3 VISTA trial data and positive analytical comparability data. ...