J&J Innovative Medicine Korea wins reimbursement for Darzalex SC regimen in newly diagnosed AL amyloidosis

4 June 2026 - Johnson & Johnson Innovative Medicine Korea said Darzalex subcutaneous injection-based quadruple regimen has received reimbursement in ...

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Pharming announces US FDA acceptance of sNDA resubmission for Joenja (leniolisib) to treat children aged 4 to 11 years with APDS

4 June 2026 - Pharming today announced that the US FDA has accepted its resubmitted supplemental new drug application seeking approval ...

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Biogen’s salanersen receives FDA breakthrough therapy designation for spinal muscular atrophy

4 June 2026 - Biogen announced today that the US FDA has granted salanersen breakthrough therapy designation for the treatment ...

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Resmetirom (Rezdiffra) authorised to treat metabolic dysfunction-associated steatohepatitis in adults

3 June 2026 - The MHRA has today authorised the medicine resmetirom (Rezdiffra) to treat adult patients with metabolic dysfunction-associated steatohepatitis. ...

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European Commission approves Amgen's Imdylltra for the treatment of extensive-stage small cell lung cancer

1 June 2026 - Amgen today announced that the European Commission has granted marketing authorisation for Imdylltra (tarlatamab) as a ...

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AbbVie announces European Commission approval of Aquipta (atogepant) for the acute treatment of migraine in adults

2 June 2026 - AbbVie today announced that the European Commission has approved Aquipta (atogepant) for the acute treatment of migraine ...

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Why Canada has generic Ozempic, and the US doesn't

3 June 2026 - Elizabeth Doran has been taking GLP-1 medications for nearly a year for weight loss to help ...

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AstraZeneca pulls critical breast cancer and endometriosis drug Zoladex from shelves

4 June 2026 - A life-saving breast cancer and endometriosis drug will be pulled from Australian shelves by a major ...

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Verastem Oncology announces US FDA fast track designation for VS-7375, an oral and potential best in class investigational KRAS G12D (ON/OFF) inhibitor for the treatment of KRAS G12D mutated locally advanced or metastatic non-small cell lung cancer

3 June 2026 - Verastem Oncology today announced that the US FDA has granted hast track designation to VS-7375, an oral ...

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Terremoto Biosciences granted FDA fast track designation for TER-2013, an AKT1 selective small molecule inhibitor for breast cancer

3 June 2026 - Terremoto Biosciences today announced that the US FDA granted fast track designation for TER-2013, the Company’s lead ...

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Cingulate receives complete response letter from FDA for CTx-1301

2 June 2026 - Cingulate today announced that the US FDA has issued a complete response letter for its new ...

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FDA approves more orphan drugs with specific cancer, paediatric indications over EMA

2 June 2026 - The US FDA is more likely to approve drugs with an orphan designation that were indicated ...

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Global tensions with US President Donald Trump could threaten affordable medicines in Australia

2 June 2026 - Australia’s access to affordable medicines could be under threat from global tensions, with one woman forced to ...

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Cheaper medicines for people fighting leukaemia and migraines

3 June 2026 - The Albanese Government is continuing to deliver cheaper medicines with Australians with types of leukaemia and ...

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TearSolutions receives FDA orphan drug and fast track designations for Lacripep in neurotrophic keratitis

2 June 2026 - TearSolutions today announced receiving FDA orphan drug and fast track designations for Lacripep in neurotrophic keratitis. ...

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