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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FDA grants breakthrough device designation to Diadem's AlzoSure predict prognostic blood test for the early prediction of Alzheimer's disease

18 January 2022 - First prognostic blood test that can predict likely progression to Alzheimer's disease up to six years in ...

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NeuroMetrix receives FDA breakthrough device designation for treatment of chronic chemotherapy induced peripheral neuropathy with its wearable neurostimulation technology

18 January 2022 - NeuroMetrix today announced that its Quell technology has received breakthrough designation from the U.S. FDA for reducing ...

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Discussion paper and online questionnaire for information session on a potential pan-Canadian formulary

18 January 2022 - On 18 January 2022, the advisory panel and CADTH will host an information session on the panel’s ...

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Antares Pharma receives FDA fast track designation for ATRS-1902 for adrenal crisis rescue

18 January 2022 - Antares Pharma today announced that the U.S. FDA has granted fast track designation for ATRS-1902 for adrenal ...

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TGA ‘knowingly putting pharmacists in serious danger’

18 January 2022 - The pharmacists’ union has accused the medical regulator of putting workers and customers at risk of ...

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TGA in review (2021)

19 January 2022 - Using a liberal definition of what constitutes a 'new medicine', we have determined the TGA approved ...

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Celularity receives fast track designation from U.S. FDA for its NK cell therapy CYNK-101 in development for the first-line treatment of advanced HER2/neu positive gastric and gastro-oesophageal junction cancers

18 January 2022 - CYNK-101 is an investigational genetically modified natural killer cell therapy designed to synergise with antibody therapeutics for ...

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COVID-19: latest safety data provide reassurance about use of mRNA vaccines during pregnancy

18 January 2022 - Vaccination remains a major pillar of the response to COVID-19, particularly as variants of the virus continue ...

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bluebird provides update on FDA review timelines for betibeglogene autotemcel for beta thalasszemia and elivaldogene autotemcel for cerebral adrenoleukodystrophy

18 January 2022 - FDA PDUFA goal dates for both therapies extended by three months. ...

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Gilead withdraws use of Zydelig to treat two types of cancer

14 January 2022 - Gilead Sciences on Friday notified the U.S. health regulator of its decision to voluntarily withdraw the ...

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Canada approves Pfizer COVID drug

18 January 2022 - Canada’s health regulator has approved a pill by Pfizer that treats the effects of COVID-19. ...

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Hyposensitisation with AR101 in peanut allergy: proof of lesser benefit

17 January 2022 - In the patient-relevant outcomes, there are only disadvantages for 4- to 17-year-olds compared to a pure peanut-avoiding ...

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Swissmedic grants temporary authorisation to Xevudy for COVID-19 patients

14 January 2022 - Corona medication Xevudy from GSK (sotrovimab) granted temporary authorisation in Switzerland ...

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Serb receives EU approval for Voraxaze (glucarpidase) as rescue therapy for high dose methotrexate toxicity

14 January 2022 -  Serb and BTG Specialty Pharmaceuticals today announced that the European Commission has granted marketing authorisation for ...

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Keytruda reimbursement boosts MSD’s R&D of follow-up drug

17 January 2022 - The government’s recognition of MSD’s Keytruda (pembrolizumab) for reimbursement as the first-line therapy for lung cancer ...

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