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RSS FeedPosted by Michael Wonder on 27 May 2021
U.S. Food and Drug Administration grants BCMA CAR-T cilta-cel priority review for the treatment for relapsed/refractory multiple myeloma
26 May 2021 - Legend Biotech has announced that the U.S. FDA has accepted for priority review the biologics license application ...
Posted by Michael Wonder on 27 May 2021
FDA authorises additional monoclonal antibody for treatment of COVID-19
26 May 2021 - Today, the U.S. FDA issued an emergency use authorisation for the investigational monoclonal antibody therapy sotrovimab for ...
Posted by Michael Wonder on 27 May 2021
Mezzion's new drug application for its orphan drug udenafil for the treatment of single ventricle heart disease has been accepted for filing by the FDA
25 May 2021 - Mezzion Pharma is pleased to announce today that it has received notice from the FDA that ...
Posted by Michael Wonder on 27 May 2021
COVID-19 vaccine weekly safety report (27 May 2021)
27 May 2021 - Nine additional cases of blood clots with low blood platelets have been assessed as thrombosis with thrombocytopenia ...
Posted by Michael Wonder on 26 May 2021
EU seeks large AstraZeneca fine
26 May 2021 - A lawyer for the European Union has accused AstraZeneca of failing to respect its contract with ...
Posted by Michael Wonder on 26 May 2021
Influencers say they were urged to criticise Pfizer vaccine
26 May 2021 - A disinformation effort to reduce public confidence in COVID-19 vaccines tried to enrol social media commentators in ...
Posted by Michael Wonder on 26 May 2021
FDA announces draft guidances to help increase transparency, assist reporting and timely completion for certain medical device studies after FDA approval or clearance
26 May 2021 - Today, the U.S. FDA issued two guidances regarding the surveillance of certain medical devices. ...
Posted by Michael Wonder on 26 May 2021
Medical device regulation comes into application
26 May 2021 - The medical device regulation, which was adopted in April 2017, changes the European legal framework for medical ...
Posted by Michael Wonder on 26 May 2021
Woebot Health receives FDA breakthrough device designation for post partum depression treatment
26 May 2021 - WB001 is the first digital therapeutic designed to reduce the burden of post partum depression. ...
Posted by Michael Wonder on 26 May 2021
Varian receives FDA breakthrough device designation for its cardiac radioablation system for treatment of refractory ventricular tachycardia
26 May 2021 - Varian's CRA system has been designated a "breakthrough device" by the FDA because of its potential to ...
Posted by Michael Wonder on 26 May 2021
Myovant Sciences and Pfizer receive FDA approval for Myfembree, the first once daily treatment for heavy menstrual bleeding associated with uterine fibroids
26 May 2021 - Myovant and Pfizer will jointly commercialise Myfembree with product availability expected in June. ...
Posted by Michael Wonder on 26 May 2021
Unity HA awarded breakthrough device designation for implantable neurostimulation technology to treat cluster headache pain
25 May 2021 - Unity HA announced today that the U.S. FDA has granted breakthrough device designation to the Pulsante SPG ...
Posted by Michael Wonder on 26 May 2021
Illuminare-1, a novel nerve visualisation investigational fluorophore, granted fast track designation by U.S. FDA
25 May 2021 - Illuminare Biotechnologies announced that its novel nerve imaging agent, Illuminare-1, has been granted fast track designation by ...
Posted by Michael Wonder on 25 May 2021
Adjusting for non-adherence or stopping treatments in randomised clinical trials
25 May 2021 - Randomised clinical trials allocate individuals to different treatments, or, more generally, to interventions and comparators, to determine ...
Posted by Michael Wonder on 25 May 2021
Spinal Stabilization Technologies earns FDA breakthrough designation for PerQdisc nucleus replacement system for degenerative disc disease
25 May 2021 - Spinal Stabilization Technologies announced today that it has earned the CE Mark and the FDA's breakthrough ...