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 24 Oct 2023
ImmunityBio announces biological license application resubmission for N-803 in BCG unresponsive non-muscle invasive bladder cancer carcinoma in situ
23 October 2023 - Following the type A meeting with the FDA, ImmunityBio has completed the BLA resubmission addressing the issues ...
Posted by Michael Wonder on 24 Oct 2023
US Food and Drug Administration accepts for review AstraZeneca’s supplemental biologics license application for self-administration of FluMist Quadrivalent
24 October 2023 - Potential to be the first and only self-administered flu vaccine. ...
Posted by Michael Wonder on 24 Oct 2023
4DMT receives EMA Priority Medicines (PRIME) designation for 4D-150 clinical stage genetic medicine for treatment of wet AMD
23 October 2023 - 4D-150 combines a novel, targeted intravitreal next generation AAV vector with a dual transgene that inhibits four ...
Posted by Michael Wonder on 24 Oct 2023
Sumitomo Pharma announces authorisation in Canada of Orogvyx (relugolix) for the treatment of men with advanced prostate cancer
23 October 2023 - Orgovyx is the first and only oral gonadotropin-releasing hormone receptor antagonist approved for advanced prostate cancer ...
Posted by Michael Wonder on 24 Oct 2023
Ipsen updates on EU marketing authorisation application for odevixibat in Alagille syndrome
23 October 2023 - Ipsen plans to submit a new marketing authorisation application for the treatment of Alagille syndrome by the ...
Posted by Michael Wonder on 23 Oct 2023
Seladelpar granted revised breakthrough therapy designation for the treatment of primary biliary cholangitis including pruritus in patients without cirrhosis or with compensated cirrhosis
23 October 2023 - CymaBay Therapeutics today announced that the US FDA has revised the originally granted breakthrough therapy designation for ...
Posted by Michael Wonder on 23 Oct 2023
NervGen Pharma receives fast track designation for NVG-291 for the treatment of individuals with spinal cord injury
23 October 2023 - NervGen Pharma today announced that the US FDA has granted fast track designation for its proprietary lead ...
Posted by Michael Wonder on 23 Oct 2023
We can’t let drug companies get out of negotiating prices
23 October 2023 - In recent months, drug manufacturers and their allies have filed 10 lawsuits attacking one of the Inflation ...
Posted by Michael Wonder on 23 Oct 2023
Ozempic and Wegovy don’t cost what you think they do
22 October 2023 - Drug companies are making billions from a new class of in demand weight loss treatments. But the ...
Posted by Michael Wonder on 23 Oct 2023
MHRA authorises bispecific antibody therapy Tepkinly as a treatment for diffuse large B-cell lymphoma in adults
20 October 2023 - Patients with recurring lymphoma, or who have not responded to prior treatments, could access a new bispecific ...
Posted by Michael Wonder on 23 Oct 2023
Enhertu approved in the EU as the first HER2 directed therapy for patients with HER2 mutant advanced non-small cell lung cancer
23 October 2023 - Approval based on DESTINY-Lung02 trial results where Daiichi Sankyo and AstraZeneca’s Enhertu demonstrated a confirmed objective ...
Posted by Michael Wonder on 23 Oct 2023
Celltrion USA announces US FDA approval of Zymfentra (infliximab-dyyb), the first and only subcutaneous infliximab, for the treatment of people with inflammatory bowel disease
22 October 2023 - Zymfentra is the first and only FDA approved subcutaneous formulation of infliximab approved for the maintenance treatment ...
Posted by Michael Wonder on 23 Oct 2023
Updates to the HTA Policy and Methods Review Reference Committee (23 October 2023)
23 October 2023 - Two more documents from the review are now available. ...
Posted by Michael Wonder on 23 Oct 2023
Life changing gene therapy for babies with spinal muscular atrophy
23 October 2023 - The Australian Government is giving more families access to life changing gene therapy for spinal muscular atrophy ...
Posted by Michael Wonder on 23 Oct 2023
1 November 2023 changes to the PBS listings of medicines for severe active rheumatoid arthritis
23 October 2023 - On 1 November 2023, changes will be made to the authority requirements of the following biological ...