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 01 Feb 2022
Pfizer and BioNTech initiate rolling submission for emergency use authorisation of their COVID-19 vaccine in children 6 months through 4 years of age following request from U.S. FDA
1 February 2022 - Companies plan to submit additional data on a third 3 µg dose in this age group in ...
Posted by Michael Wonder on 01 Feb 2022
Aussie device that gives eyes to the blind fast tracked in US
1 February 2022 - A world-first bionic eye that restores partial vision to the blind has been given “breakthrough” designation ...
Posted by Michael Wonder on 01 Feb 2022
Veru announces FDA grant of fast track designation for sabizabulin for the treatment of hospitalised COVID-19 patients at high risk for acute respiratory distress syndrome
31 January 2022 - Second Veru drug under development to receive FDA fast track designation this month. ...
Posted by Michael Wonder on 01 Feb 2022
U.S. FDA approves new label update for CAR T-cell therapy Yescarta showing prophylactic steroid use improves management of cytokine release syndrome
31 January 2022 - Updated toxicity management strategy can improve certain adverse events without compromising the activity of Yescarta. ...
Posted by Michael Wonder on 01 Feb 2022
Blue Note Therapeutics receives breakthrough device designation for prescription only digital therapeutic for acute myeloid leukaemia
31 January 2022 - Blue Note Therapeutics, a prescription digital therapeutics company dedicated to easing the burden of cancer and improving ...
Posted by Michael Wonder on 01 Feb 2022
ViiV Healthcare announces US FDA approval of Cabenuva (cabotegravir, rilpivirine) for use every two months, expanding the label of the first and only complete long-acting HIV treatment
1 February 2022 - Cabenuva is now approved for administration as few as six times a year for virologically suppressed ...
Posted by Michael Wonder on 01 Feb 2022
Byannli authorised in Britain for schizophrenia treatment
1 February 2022 - Market authorisation for twice yearly schizophrenia treatment which offers patients much-needed medication continuity ...
Posted by Michael Wonder on 01 Feb 2022
FDA approves prophylactic treatment with Vonvendi [von Willebrand factor (recombinant)] for adult patients living with severe type 3 von Willebrand disease
31 January 2022 - Vonvendi [von Willebrand factor (recombinant)] is the first and only treatment approved for routine prophylaxis to reduce ...
Posted by Michael Wonder on 01 Feb 2022
Reata Pharmaceuticals initiates rolling submission of new drug application with U.S. FDA for omaveloxolone for the treatment of patients with Friedreich’s ataxia
31 January 2022 - Plans to complete submission by the end of the first quarter of 2022. ...
Posted by Michael Wonder on 01 Feb 2022
'Lifesaving' cystic fibrosis drug Trikafta recommended for inclusion on PBS
1 February 2022 - Thousands of people with cystic fibrosis are one step closer to accessing a 'lifesaving' drug, after ...
Posted by Michael Wonder on 01 Feb 2022
Four million additional Australians eligible for their booster dose
31 January 2022 - Over four million additional Australians are now eligible for their COVID-19 booster dose from today, with the ...
Posted by Michael Wonder on 01 Feb 2022
Janssen submits marketing authorisation application to the EMA seeking approval of bispecific antibody teclistamab for the treatment of patients with relapsed or refractory multiple myeloma
31 January 2022 - The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a marketing authorisation application ...
Posted by Michael Wonder on 01 Feb 2022
Celltrion Healthcare announces Canadian approval of Yuflyma, a high concentration, low volume, citrate free and latex free Humira (adalimumab) biosimilar
31 January 2022 - Yuflyma brings a new offering to healthcare practitioners and their patients with inflammatory diseases in Canada. ...
Posted by Michael Wonder on 01 Feb 2022
Applaud Medical receives FDA breakthrough device designation for the company’s acoustic enhancer for use in conjunction with ureteroscopy with laser lithotripsy for the fragmentation of calcium based kidney stones
31 January 2022 - Applaud Medical today announced that its acoustic enhancer technology has received breakthrough device designation from the U.S. ...
Posted by Michael Wonder on 01 Feb 2022
CDER explores series of draft guidances on real world data, real world evidence - drug information update
31 January 2022 - Collection and analysis of real world data continue to gain traction in the biomedical community, accompanied by ...