COVID-19: EMA recommends conditional marketing authorisation for Paxlovid

27 January 2022 - The EMA’s CHMP has recommended granting a conditional marketing authorisation for the oral antiviral medicine Paxlovid ...

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Omeros confirms submission of response to FDA regarding the BLA for narsoplimab in the treatment of HSCT-TMA

19 January 2022 - Omeros Corporation today confirmed that earlier this month the company submitted to the U.S. FDA its response ...

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Pathogenomix granted FDA breakthrough device designation

19 January 2022 - Patho-Seq uses next generation sequencing to rapidly identify bacteria from human samples during dangerous and life-threatening ...

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Two anti-viral COVID-19 treatments approved

20 January 2022 - The Australian Government welcomes the Therapeutic Goods Administration’s provisional approval of the first oral treatments for COVID-19 ...

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ChemoCentryx announces EU approval of Tavneos (avacopan) for the treatment of ANCA associated vasculitis

19 January 2022 - ChemoCentryx today announced that Tavneos (avacopan) has been approved within the European Union in combination with a ...

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Celcuity receives FDA fast track designation for gedatolisib in HR positive, HER2 negative metastatic breast cancer

18 January 2022 - On track to finalise Phase 3 clinical trial design for gedatolisib with FDA feedback in first quarter. ...

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TGA provisionally approves Novavax (Biocelect) COVID-19 vaccine Nuvaxovid

20 January 2022 - The Therapeutic Goods Administration has granted provisional approval to Biocelect (on behalf of Novavax) for its ...

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Beyond survival: the US FDA confirms surrogate end points for patients with newly diagnosed acute myeloid leukaemia treated with intensive chemotherapy

10 January 2022 - The treatment of acute myeloid leukaemia has rapidly evolved over the past decade.  ...

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TGA provisionally approves two oral COVID-19 treatments, molnupiravir (Lagevrio) and nirmatrelvir and ritonavir (Paxlovid)

20 January 2022 - The TGA has granted provisional approval to two oral COVID-19 treatments: Paxlovid (nirmatrelvir and ritonavir, Pfizer) ...

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Lieutenant General John Frewen says he expects TGA approval of Novavax vaccine is 'imminent'

19 January 2022 - The head of Australia's vaccine rollout expects one to two per cent of Australians who remain unvaccinated ...

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Sensydia receives FDA breakthrough device designation for CPS non-invasive cardiac monitoring device

19 January 2022 - Sensydia today announced that its cardiac performance system has been granted breakthrough device designation by the United ...

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UK’s NICE to launch sweeping changes to drug assessments to be faster, more agile

19 January 2022 - The health technology assessment body has been under pressure from drugmakers and patient groups for years to ...

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FDA accepts for review Libtayo (cemiplimab-rwlc) in combination with chemotherapy for first-line treatment of advanced NSCLC

19 January 2022 - Regulatory filing recently submitted in the European Union. ...

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Levo Therapeutics receives complete response letter from FDA for its new drug application for LV-101 (intranasal carbetocin) for the treatment of Prader-Willi syndrome

18 January 2022 - Levo Therapeutics announced today that it has received a complete response letter from the U.S. FDA regarding ...

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CANbridge Pharmaceuticals CAN108 new drug application for Alagille syndrome accepted by China’s National Medical Products Administration

17 January 2022 - Priority review expected to be granted. ...

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Early benefit assessment for new drugs 2021: G-BA sets a record with 146 completed procedures

10 January 2022 - At the beginning of the year, the Federal Joint Committee (G-BA) took stock of its assessment of ...

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