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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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. ...

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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 ...

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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 ...

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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 ...

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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, ...

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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 ...

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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 ...

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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. ...

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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 ...

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