US FDA seeks more information on Maxigesic IV application

1 July 2022 - Hyloris Pharmaceuticals announces that it has today received a complete response letter from the US FDA on ...

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COVID-19 vaccine safety report (30 June 2022)

30 June 2022 - The Australian Government has decided the COVID-19 vaccine safety report will now be published fortnightly instead of ...

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Aura Biosciences receives FDA fast track designation for belzupacap sarotalocan (AU-011) for the treatment of non-muscle invasive bladder cancer

30 June 2022 - Aura Biosciences today announced that the U.S. FDA has granted fast track designation for belzupacap sarotalocan (AU-011), ...

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Pfizer announces submission of new drug application to the U.S. FDA for Paxlovid

30 June 2022 - Final results from EPIC-HR study showed an 86% reduction in relative risk of hospitalisations or death from ...

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Review into COVID-19 vaccine and treatment purchases

30 June 2022 - The Australian Government is undertaking an independent review of Australia’s vaccine and treatment procurements, led by former ...

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From FDA to MHRA: are drug regulators for hire?

29.June 2022 - Patients and doctors expect drug regulators to provide an unbiased, rigorous assessment of investigational medicines before they hit ...

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Provisional determination granted to Pfizer in relation to COVID 19 vaccine (Comirnaty) - for use in individuals 6 months up to 5 years

30 June 2022 - On 28 June 2022, the TGA granted a provisional determination to Pfizer Australia in relation to ...

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Patient focused drug development: selecting, developing, or modifying fit for purpose clinical outcome assessments

29 June 2022 - This guidance (Guidance 3) is the third in a series of four methodological patient-focused drug development (PFDD) ...

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Clinical benefit and expedited approval of cancer drugs in the United States, European Union, Switzerland, Japan, Canada, and Australia

22 June 2022 - Regulatory agencies have sought to speed up the review of new cancer medicines and reduce delays in ...

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Janssen announces U.S. FDA breakthrough therapy designation granted for talquetamab for the treatment of relapsed or refractory multiple myeloma

29 June 2022 - Novel GPRC5DxCD3 bispecific antibody receives breakthrough therapy designation based upon results from the Phase 1/2 MonumenTAL-1 study. ...

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Bavarian Nordic announces grant of PRIME eligibility from the EMA for its RSV vaccine candidate for the prevention of respiratory syncytial virus in older adults

28 June 2022 - Bavarian Nordic announced today that the EMA has granted access to its priority medicines (PRIME) scheme for ...

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Eylea (aflibercept) injection sBLA for every 16 week dosing regimen in patients with diabetic retinopathy accepted for FDA review

29 June 2022 - If approved, extended regimen would provide a longer treatment interval and additional dosing flexibility, alongside approved ...

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Ipsen announces U.S. FDA priority review for palovarotene new drug application in patients with fibrodysplasia ossificans progressiva following resubmission

29 June 2022 - Ipsen today announced that the U.S. FDA has accepted for priority review its resubmitted new drug ...

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Health Canada approves Opdivo (nivolumab) as monotherapy for the adjuvant treatment of adults with urothelial carcinoma at high risk of recurrence after undergoing radical resection of urothelial carcinoma

28 June 2022 - First adjuvant Immunotherapy for patients at high risk of disease recurrence. ...

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Monkeypox: EMA starts review for Imvanex

28 June 2022 - The EMA’s CHMP has started a review of data to extend the use of the smallpox ...

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