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RSS FeedPosted by Michael Wonder on 30 Jul 2021
Erytech granted U.S. FDA fast track designation for Eryaspase in hypersensitive ALL
29 July 2021 - Fast track designation for eryaspase underscores the need for new treatment options for patients who developed ...
Posted by Michael Wonder on 29 Jul 2021
Ardelyx receives complete response letter from U.S. FDA for new drug application for tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis
29 July 2021 - Ardelyx today announced that it has received a complete response letter from the U.S. FDA regarding ...
Posted by Michael Wonder on 29 Jul 2021
Congress presses the FDA to move faster on ALS drugs
29 July 2021 - Lawmakers pressed a top FDA official Thursday for answers on why the agency has balked at approving ...
Posted by Michael Wonder on 29 Jul 2021
FDA says it's working as fast as possible to fully approve vaccines, as urgency rises amid COVID-19 surge
29 July 2021 - The US FDA insists it is working as quickly as possible to review applications for full ...
Posted by Michael Wonder on 29 Jul 2021
FDA approves expanded Botox (onabotulinumtoxinA) label to include eight new muscles to treat adults with upper limb spasticity
29 July 2021 - Botox has demonstrated efficacy and has an established safety profile with over 10 years of clinical ...
Posted by Michael Wonder on 29 Jul 2021
Biofourmis earns FDA's first ever breakthrough device designation for a novel digital therapeutic for heart failure
29 July 2021 - BiovitalsHF approved for expedited FDA review process as a first-in-class digital therapeutic for heart failure that augments ...
Posted by Michael Wonder on 29 Jul 2021
Arrowhead Pharmaceuticals receives breakthrough therapy designation from U.S. FDA for ARO-AAT for the treatment of alfa-1 anti-trypsin deficiency associated liver disease
29 July 2021 - Full enrollment reached in Phase 2 SEQUOIA study of ARO-AAT. ...
Posted by Michael Wonder on 29 Jul 2021
FDA accepts application for Genentech’s faricimab for the treatment of wet age-related macular degeneration and diabetic macular oedema
28 July 2021 - Across four Phase 3 studies, approximately half of patients receiving faricimab could extend treatment time to every ...
Posted by Michael Wonder on 29 Jul 2021
COVID-19 vaccine weekly safety report (29 July 2021)
29 July 2021 - Over the last week, six additional cases of blood clots with low blood platelets have been assessed ...
Posted by Michael Wonder on 29 Jul 2021
FDA authorizes baricitinib alone as treatment for COVID-19
28 July 2021 - Today, the U.S. FDA revised the Emergency Use Authorisation for baricitinib (Olumiant) now authorising baricitinib alone for ...
Posted by Michael Wonder on 29 Jul 2021
GSK and Vir Biotechnology announce Joint Procurement Agreement with European Commission for COVID-19 treatment sotrovimab
28 July 2021 - GSK and Vir Biotechnology today announced they have signed a Joint Procurement Agreement with the European ...
Posted by Michael Wonder on 28 Jul 2021
Controversy and progress in Alzheimer’s disease — FDA approval of aducanumab
28 July 2021 - The FDA’s accelerated approval of aducanumab represents a landmark moment, though the drug’s road to the clinic ...
Posted by Michael Wonder on 28 Jul 2021
Revisiting FDA approval of aducanumab
28 July 2021 - Given the scientific, regulatory, and clinical implications of the accelerated FDA approval of aducanumab for Alzheimer’s disease, ...
Posted by Michael Wonder on 28 Jul 2021
FDA approves first interchangeable biosimilar insulin product for treatment of diabetes
28 July 2021 - Availability of insulin products will help increase access and potentially lower the cost of insulin for people ...
Posted by Michael Wonder on 28 Jul 2021
U.S. FDA grants breakthrough therapy designation to Takeda’s investigational compound, TAK-994, an oral orexin agonist in clinical development for narcolepsy Type 1
29 July 2021 - If approved, investigational TAK-994 may provide a future treatment option targeting the orexin deficiency underlying narcolepsy ...