FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease

29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...

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Government of Canada negotiates additional agreement with Moderna for vaccine supply beyond 2021

13 August 2021 - The Government of Canada is committed to protecting the health and safety of Canadians by securing ...

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Artificial intelligence in medicine regulation

16 August 2021 - The International Coalition of Medicines Regulatory Authorities sets out recommendations to help regulators to address the ...

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InxMed's IN10018 receives U.S. FDA fast track designation for the treatment of platinum-resistant ovarian cancer

16 August 2021 - InxMed announced today the U.S. FDA has granted fast track designation to IN10018 for the treatment of ...

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U.S. FDA approves Ticovac, Pfizer's tick borne encephalitis vaccine

13 August 2021 - Ticovac may help reduce the risk of tick-borne encephalitis for people traveling to endemic areas, potentially including ...

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Australia secures one million Pfizer doses from Poland, with more than half destined for Sydney

15 August 2021 - Poland has come to Australia’s rescue with an extra one million Pfizer doses after the government went ...

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PHARMAC invites entire staff to top secret drug ranking meetings

16 August 2021 - Highly confidential meetings where PHARMAC ranks the funding priority of potentially life-saving medicines are open to ...

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Coronavirus (COVID-19) update: FDA authorises additional vaccine dose for certain immunocompromised individuals

12 August 2021 - Other fully vaccinated individuals do not need an additional vaccine dose right now. ...

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Sesen Bio receives complete response letter from FDA for Vicineum (oportuzumab monatox-qqrs)

Sesen Bio today announced that it received a complete response letter from the U.S. FDA regarding its biologics license application ...

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Genomic diagnostic tests face persistent pricing and reimbursement challenges

13 August 2021 - Twenty years ago, the mapping of the human genome promised new opportunities for genomic or genetic tests ...

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Halifax man devastated after insurer reverses decision to cover $25,000 cystic fibrosis drug

13 August 2021 - Stefan Strecko says he's pleaded with Canada Life to cover cost of 'miracle' drug. ...

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Ipsen announces withdrawal of palovarotene NDA, confirming intention to resubmit following additional data analyses

13 August 2021 - This follows ongoing dialogue with the U.S. FDA regarding the palovarotene NDA review, initiated in May ...

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FDA approves belzutifan for cancers associated with von Hippel-Lindau disease

13 August 2021 - Today the FDA approved belzutifan (Welireg, Merck), a hypoxia-inducible factor inhibitor for adult patients with von ...

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Congress should fix FDA’s accelerated approval program for the next 30 years

12 August 2021 - The FDA's approval of the Alzheimer’s drug Aduhelm has sparked a broader debate on the merits ...

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Making vaccines available to other countries before offering domestic booster vaccinations

12 August 2021 - On July 8, 2021, Pfizer and BioNTech announced they would be seeking US and European authorisation ...

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GC Pharma announces GreenGene F approval in China for the treatment of haemophilia A

12 August 2021 - GreenGene F now approved in China, provides more haemophilia A patients access to proven therapy. ...

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