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 31 Oct 2021
FDA authorises Pfizer-BioNTech COVID-19 vaccine for emergency use in children 5 through 11 years of age
29 October 2021 - Today, the U.S. FDA authorised the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of ...
Posted by Michael Wonder on 31 Oct 2021
U.S. Food and Drug Administration Approves Vuity (pilocarpine hydrochloride 1.25% ophthalmic solution) the first and only eye drop to treat presbyopia (age related blurry near vision)
29 October 2021 - Presbyopia, or age related blurry near vision, is a common, progressive condition that reduces the eye's ability ...
Posted by Michael Wonder on 31 Oct 2021
Novartis UK awarded Innovation Passport for investigational therapy
29 October 2021 - Novartis have announced that the investigational oral therapy, iptacopan (LNP023), has been awarded an Innovation Passport ...
Posted by Michael Wonder on 30 Oct 2021
FDA approves Novartis Scemblix (asciminib) with novel mechanism of action for the treatment of chronic myeloid leukemia
29 October 2021 - Scemblix provides much-needed and long-awaited new option for patients with chronic myeloid leukaemia who suffer with intolerance ...
Posted by Michael Wonder on 29 Oct 2021
Kite's Tecartus (brexucabtagene autoleucel) authorised by Health Canada for the treatment of relapsed or refractory mantle cell lymphoma
28 October 2021 - Tecartus is first CAR T therapy in mantle cell lymphoma and Kite becomes the first company ...
Posted by Michael Wonder on 29 Oct 2021
Public Summary Documents – July 2021 PBAC meeting
29 October 2021 - The public summary documents (positive recommendations and subsequent decisions not to recommend) from the July 2021 PBAC ...
Posted by Michael Wonder on 29 Oct 2021
Incyte announces the validation of the European marketing authorisation application for ruxolitinib cream in vitiligo
28 October 2021 - The marketing authorisation application seeks approval of ruxolitinib cream for the treatment of adolescent and adult patients ...
Posted by Michael Wonder on 29 Oct 2021
Reata Pharmaceuticals submits marketing authorisation application to the EMA for bardoxolone methyl in chronic kidney disease caused by Alport syndrome
28 October 2021 - Reata Pharmaceuticals today announced its submission of a marketing authorisation application for bardoxolone methyl to the ...
Posted by Michael Wonder on 29 Oct 2021
CytoDyn announces FDA accepts revised rolling review timeline for resubmission of its BLA
28 October 2021 - Management expects the non-clinical and CMC sections of the BLA to be resubmitted to FDA in ...
Posted by Michael Wonder on 29 Oct 2021
PBS arrangements for tocilizumab shortage – 1 November 2021
29 October 2021 - In response to the shortages of multiple presentations of tocilizumab (Actemra) products, the PBAC has recommended temporary ...
Posted by Michael Wonder on 28 Oct 2021
NICE publishes final guidance for Janssen's apalutamide
28 October 2021 - Final guidance for two indications. ...
Posted by Michael Wonder on 28 Oct 2021
FDA acknowledges hurdles in utilising real world data
28 October 2021 - FDA is seeking to address the added complexities for incorporating real-world data and real-world evidence into ...
Posted by Michael Wonder on 28 Oct 2021
Biden abandons his push to lower drug prices
28 October 2021 - The White House is abandoning every single policy idea aimed at lowering prescription drug prices in ...
Posted by Michael Wonder on 28 Oct 2021
Mallinckrodt and Terumo Blood and Cell Technologies announce positive recommendations in Australia for public funding of Uvadex (methoxsalen) for ECP administration with the Therakos Cellex photopheresis system for chronic graft versus host disease in adults
28 October 2021 - In a dual review process, two independent advisory committees to the Australian Minister for Health recommended reimbursement ...
Posted by Michael Wonder on 28 Oct 2021
Spero Therapeutics submits new drug application to U.S. FDA for tebipenem hydrobromide for the treatment of complicated urinary tract infections including pyelonephritis
28 October 2021 - Spero Therapeutics today announced the submission of a new drug application to the U.S. FDA, seeking approval ...