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RSS FeedPosted by Michael Wonder on 30 Jul 2021
GSK announces FDA approval for Nucala (mepolizumab) for use in adults with chronic rhinosinusitis with nasal polyps
29 July 2021 - First IL-5 therapy approved as an add-on treatment in the US for adults with chronic rhinosinusitis with ...
Posted 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
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
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 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 ...
Posted by Michael Wonder on 28 Jul 2021
Mycovia Pharmaceuticals announces U.S. FDA acceptance and priority review of new drug application for oteseconazole for the treatment of recurrent vulvovaginal candidiasis
28 July 2021 - Six month priority review granted for oteseconazole with PDUFA target action date set for 27 January 2022. ...
Posted by Michael Wonder on 28 Jul 2021
Apic Bio receives FDA fast track designation for APB-102 for the treatment of patients with SOD1 ALS
28 July 2021 - Apic Bio today announced that the U.S. FDA has granted fast track designation to APB-102, the ...