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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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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Junshi Biosciences announces two additional indications for toripalimab included in China’s National Reimbursement Drug List

3 December 2021 - The only anti-PD-1 monoclonal antibody in the NRDL for melanoma and nasopharyngeal carcinoma. ...

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Theratechnologies submits supplemental biologics license application to FDA advancing development of IV push Trogarzo for patients living with HIV

6 December 2021 - sBLA submission with FDA follows on the back of recently announced positive TMB-302 study results. ...

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Sapience Therapeutics receives FDA fast track designation for ST101 for the treatment of recurrent glioblastoma multiforme

6 December 2021 -  Sapience Therapeutics announced today that the U.S. FDA has granted fast track designation to its lead ...

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HCF calls for independent regulator of medical devices

6 December 2021 - Health insurer HCF has raised concerns that some doctors may be deciding what device to implant­ ...

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EMA recommends approval for use of RoActemra in adults with severe COVID-19

6 December 2021 - The EMA’s CHMP has recommended extending the indication of RoActemra (tocilizumab) to include the treatment of ...

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TGA provisional approval of Celltrion COVID-19 treatment regdanvimab (Regkirona)

6 December 2021 - On 6 December 2021, the TGA granted provisional approval to Celltrion Healthcare for the use of ...

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PHARMAC negotiates deal with Pfizer for its promising new oral antiviral treatment for COVID-19

6 December 2021 - PHARMAC has negotiated an agreement with Pfizer for its promising new oral anti-viral treatment to treat ...

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Secura Bio announces Copiktra (duvelisib) strategic focus on T-cell lymphoma and voluntary U.S. withdrawal of the relapsed or refractory follicular lymphoma indication

3 December 2021 - Secura Bio has voluntarily withdrawn the U.S. Copiktra indication for the treatment of patients with relapsed or ...

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Chiesi Global Rare Diseases announces updated U.S. Prescribing Information for Ferriprox (deferiprone)

3 December 2021 - Chiesi Global Rare Diseases announced today that the Ferriprox (deferiprone) Prescribing Information in the U.S. has been ...

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RefleXion receives breakthrough device designation for lung cancer treatment

1 December 2021 - RefleXion Medical today announced that the U.S. FDA has granted the company breakthrough device designation for ...

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FDA approves new Kyprolis (carfilzomib) combination regimen with Darzalex Faspro (daratumumab and hyaluronidase-fihj) and dexamethasone for patients with multiple myeloma at first or subsequent relapse

1 December 2021 - Kyprolis in combination with subcutaneous treatment regimen provides further options and convenience for patients with relapsed/refractory ...

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