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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 Dec 2021
FDA accepts Arcutis Biotherapeutics’ new drug application for roflumilast cream for adults and adolescents with plaque psoriasis
22 December 2021 - FDA has set a target action date of 29 July 2022. ...
Posted by Michael Wonder on 31 Dec 2021
Lexicon submits new drug application for sotagliflozin for the treatment of heart failure in adults with type 2 diabetes
30 December 2021 - ) -- Lexicon Pharmaceuticals today announced that it has submitted a new drug application to the U.S. ...
Posted by Michael Wonder on 31 Dec 2021
Amylyx Pharmaceuticals announces FDA acceptance and priority review of new drug application for AMX0035 for the treatment of ALS
29 December 2021 - Amylyx Pharmaceuticals today announced that the U.S. FDA has accepted for review its new drug application for ...
Posted by Michael Wonder on 30 Dec 2021
Janssen submits biologics license application to U.S. FDA seeking approval of teclistamab for the treatment of patients with relapsed or refractory multiple myeloma
29 December 2021 - Janssen announced today the submission of a biologics license application to the U.S. FDA seeking approval ...
Posted by Michael Wonder on 30 Dec 2021
PBS listing for Braftovi and cetuximab for metastatic bowel cancer patients with BRAFV600 mutation
30 December 2021 - Pierre Fabre Australia today announced that Braftovi (encorafenib) in combination with cetuximab will be listed on the ...
Posted by Michael Wonder on 29 Dec 2021
Valemetostat new drug application submitted in Japan for treatment of patients with adult T-cell leukaemia/lymphoma
28 December 2021 - Submission of orphan drug designated valemetostat based on pivotal phase 2 trial in patients with relapsed/refractory adult T-cell ...
Posted by Michael Wonder on 29 Dec 2021
Swiss regulator approves Roche-Regeneron COVID-19 drug
27 December 2021 - The Swiss medicines agency, Swissmedic, has given the green light to the monoclonal antibody cocktail Ronapreve developed ...
Posted by Michael Wonder on 29 Dec 2021
Janssen COVID-19 booster shot approved in Switzerland
28 December 2021 - Medicines regulator Swissmedic has approved the booster of the single-dose vaccine from Johnson & Johnson. ...
Posted by Michael Wonder on 29 Dec 2021
LEO Pharma announces FDA approval of Adbry (tralokinumab) as the first and only treatment specifically targeting IL-13 for adults with moderate to severe atopic dermatitis
28 December 2021 - Adbry is the first biologic launched by LEO Pharma in the United States and is expected to ...
Posted by Michael Wonder on 28 Dec 2021
ICER to assess treatments for Alzheimer’s disease
22 December 2021 - Report will be subject of CTAF meeting in July 2022; draft scoping document open to public ...
Posted by Michael Wonder on 28 Dec 2021
COVID-19 vaccine weekly safety report (23 December 2021)
23 December 2021 - To 19 December 2021, the TGA has received 415 reports which have been assessed as likely to ...
Posted by Michael Wonder on 28 Dec 2021
Trastuzumab deruxtecan type II variation application validated by EMA for patients with HER2 positive metastatic breast cancer treated with a prior anti-HER2 based regimen
28 December 2021 - Application based on DESTINY-Breast03 results showing Daiichi Sankyo and AstraZeneca’s trastuzumab deruxtecan reduced risk of disease progression ...
Posted by Michael Wonder on 28 Dec 2021
Vivoryon Therapeutics receives FDA fast track designation for varoglutamstat in early Alzheimer’s disease
22 December 2021 - 21 – Vivoryon Therapeutics today announced that the U.S. FDA has granted fast track designation for varoglutamstat ...
Posted by Michael Wonder on 27 Dec 2021
Celularity receives fast track designation from U.S. FDA for its NK cell therapy CYNK-001 in development for the treatment of AML
27 December 2021 - Celularity today announced the U.S. FDA has granted fast track designation for its non-genetically modified cryopreserved human ...
Posted by Michael Wonder on 27 Dec 2021
FDA approves add-on therapy to lower cholesterol among certain high-risk adults
22 December 2021 - FDA has approved Leqvio (inclisiran) injection as a treatment to be used along with diet and maximally ...