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RSS FeedPosted 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
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
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 ...
Posted by Michael Wonder on 01 Feb 2022
Novavax submits request to the U.S. FDA for emergency use authorisation of COVID-19 Vaccine
31 January 2022 - NVX-CoV2373 demonstrated overall efficacy of ~90% in PREVENT-19 clinical trial conducted during the emergence of variant ...
Posted by Michael Wonder on 31 Jan 2022
Coronavirus (COVID-19) update: FDA takes key action by approving second COVID-19 vaccine
31 January 2022 - Today, the U.S. FDA approved a second COVID-19 vaccine. ...
Posted by Michael Wonder on 30 Jan 2022
FDA approves Genentech’s Vabysmo, the first bispecific antibody for the eye, to treat two leading causes of vision loss
28 January 2022 - Vabysmo (faricimab-svoa) targets and inhibits two disease pathways that drive wet age-related macular degeneration and diabetic macular ...
Posted by Michael Wonder on 28 Jan 2022
Updates on Olumiant (baricitinib) FDA review for atopic dermatitis
28 January 2022 - Eli Lilly and Incyte today announced updates on the Phase 3 development program for Olumiant (baricitinib) in ...
Posted by Michael Wonder on 28 Jan 2022
Regeneron and Sanofi provide regulatory update on Libtayo (cemiplimab-rwlc) in advanced cervical cancer
28 January 2022 - Regeneron Pharmaceuticals and Sanofi today announced the voluntary withdrawal of the supplemental biologics license application for Libtayo ...