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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Remarks by President Biden on prescription drug costs

6 December 2021 - Today, I’d like to talk about how we’re going to help millions of Americans protect and ...

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FDA approves Octapharma’s Cutaquig 16.5% for paediatric PI patients, providing flexible treatment options

7 December 2021 - Families, providers can utilise flexible infusion schedule to meet patient needs. ...

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Linus Biotechnology receives FDA breakthrough device designation for StrandDx-ASD exposome sequencing diagnostic

7 December 2021 - Linus Biotechnology  today announced that the U.S. Food and Drug Administration Center for Devices and Radiological Health ...

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Zai Lab announces inclusion of Zejula (niraparib) in China’s National Reimbursement Drug List for first-line ovarian cancer

3 December 2021 - Zai Lab today announced that the National Reimbursement Drug List released by China’s National Healthcare Security Administration ...

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U.S. plans to fast track revamped COVID-19 vaccines

5 December 2021 - Study from South Africa suggests the fast-spreading Omicron variant might cause less severe illness than its predecessors. ...

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China clears insurance coverage for Kainos Medicine’s HIV drug

6 December 2021 - A home-grown HIV treatment developed by Kainos Medicine and out-licensed to China’s Jiangsu Aidea Pharmaceuticals has ...

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Spectrum Pharmaceuticals submits new drug application for poziotinib

6 December 2021 - Fast track application is based on positive data in NSCLC HER2 exon 20 insertion mutations in previously ...

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EMA accepts regulatory submission for olipudase alfa, the first potential therapy for ASMD

6 December 2021 - Olipudase alfa has been granted PRIority MEdicines (PRIME) designation in Europe, breakthrough therapy designation in the United ...

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ICMRA high-level meeting on global health emergencies and regulatory approaches

6 December 2021 - On 1 - 2 December, International Coalition of Medicines Regulatory Authorities, a group of leading medicines regulatory ...

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Biosimilar follitropin alfa on the PBS - information for health care professionals and patients

7 December 2021 - A biosimilar brand of follitropin alfa (Ovaleap) was listed on the PBS on 1 December 2021.  ...

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Product approval and public health at the US Food and Drug Administration

6 December 2021 - Since the 1962 Kefauver-Harris Amendments to the Federal Food, Drug, and Cosmetic Act, drug approval in ...

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Ascletis announces inclusion in new catalogue of China National Reimbursement Drug List of Asclevir/Ganovo regimen, an all oral direct anti-HCV therapy

2 December 2021 - Ascletis Pharma today announces that its all-oral direct anti-hepatitis C virus Asclevir (ravidasvir)/Ganovo (danoprevir) regimen has been ...

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Critics blame diabetes deaths on PHARMAC taking years to fund new drug

6 December 2021 - Diabetes Foundation Aotearoa says PHARMAC's delay funding new diabetes drugs has led to many deaths in Māori ...

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BeiGene announces inclusion in the China National Reimbursement Drug List (NRDL) of tislelizumab in three new indications, Brukinsa (zanubrutinib) in one new indication, and the first listing for pamiparib

2 December 2021 - BeiGene today announced that three of its medicines have been added to the most recent National Reimbursement ...

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Shining a light on PHARMAC

6 December 2021 - It is encouraging to read the country’s drug buying agency PHARMAC is already moving to improve ...

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