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 21 Dec 2021
Sandoz submits biologics license application for proposed biosimilar trastuzumab to US FDA
20 December 2021 - Biologics license application is supported by analytical, pre-clinical and clinical data, proposed biosimilar trastuzumab developed by EirGenix. ...
Posted by Michael Wonder on 20 Dec 2021
Biased Outcome reporting Guidelines for Underwhelming Studies (BOGUS) statement and checklist
10 December 2021 - A light hearted article to end the year. Merry Christmas to all our readers. We will ...
Posted by Michael Wonder on 20 Dec 2021
NICE recommends monotherapy for adjuvant treatment of stage 3 melanoma
17 December 2021 - The approval follows a successful period of monitoring and patient access through the Cancer Drugs Fund. ...
Posted by Michael Wonder on 20 Dec 2021
EMA recommends Nuvaxovid for authorisation in the EU
20 December 2021 - EMA has recommended granting a conditional marketing authorisation for Novavax’s COVID-19 vaccine Nuvaxovid (also known as ...
Posted by Michael Wonder on 20 Dec 2021
Biogen cuts price for Alzheimer’s drug Aduhelm by half
20 December 2021 - The drug has sold poorly since its approval in June due to concerns about its safety, effectiveness ...
Posted by Michael Wonder on 20 Dec 2021
EMA adopts a positive CHMP opinion for Pfizer’s and OPKO’s somatrogon, a long-acting treatment for paediatric growth hormone deficiency
17 December 2021 - If approved by the European Commission, somatrogon will offer children and adolescents living with growth hormone ...
Posted by Michael Wonder on 20 Dec 2021
Edenbridge Pharmaceuticals announces U.S. FDA approval of Dartisla ODT (glycopyrrolate) orally disintegrating tablets
17 December 2021 - First and only orally disintegrating tablet of glycopyrrolate. ...
Posted by Michael Wonder on 20 Dec 2021
Saphnelo recommended for approval in the EU by CHMP for the treatment of patients with systemic lupus erythematosus
20 December 2021 - Saphnelo is a first-in-class type I interferon receptor antibody shown to reduce overall disease activity in ...
Posted by Michael Wonder on 20 Dec 2021
CHMP issues positive opinion for Pfizer’s 20 valent pneumococcal conjugate vaccine for the prevention of vaccine type pneumococcal pneumonia in adults
17 December 2021 - Pfizer announced today that the CHMP of the EMA has issued a positive opinion to recommend the ...
Posted by Michael Wonder on 20 Dec 2021
New treatment for heart failure to support thousands of Australian patients
20 December 2021 - From 1 January 2022, tens of thousands of Australians with symptomatic heart failure will have access to ...
Posted by Michael Wonder on 20 Dec 2021
PHARMAC’s year in review
20 December 2021 - Today PHARMAC has released its Year in Review for 2021, an annual publication highlighting key aspects of ...
Posted by Michael Wonder on 19 Dec 2021
Injectafer (ferric carboxymaltose injection) receives FDA approval for the treatment of paediatric patients with iron deficiency anaemia
15 December 2021 - For patients as young as one year of age who have intolerance to, or have had ...
Posted by Michael Wonder on 19 Dec 2021
FDA approves Telix’s prostate cancer imaging product, Illuccix
19 December 2021 - Telix Pharmaceuticals today announces that the United States FDA has approved Telix’s lead prostate cancer imaging product, ...
Posted by Michael Wonder on 19 Dec 2021
Pfizer receives positive CHMP opinion for Lorviqua (lorlatinib) as first-line treatment for ALK positive advanced lung cancer
17 December 2021 - Recommendation based on results from the Phase 3 CROWN trial, which showed Lorviqua reduced the risk of ...
Posted by Michael Wonder on 19 Dec 2021
Xalud Therapeutics receives FDA fast track designation for XT-150 for the treatment of pain associated with osteoarthritis of the knee
17 December 2021 - Xalud Therapeutics announced today that the United States FDA has granted fast track designation to the Company’s ...