Diakonos Oncology awarded fast track designation by FDA for DOC1021 (dubodencel) in unresectable or metastatic cutaneous melanoma

6 May 2026 - Diakonos Oncology announced today that the US FDA has granted fast track designation to DOC1021, the ...

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ICER publishes protocol for annual launch price and access report

4 May 2026 - The ICER posted a protocol today outlining how it will conduct its second annual analysis titled the ...

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Healyth Canada authorised Lilly's Kisunla (donanemab), a new treatment for early Alzheimer's disease

4 May 2026 - Today, after more than 35 years of commitment to advancing Alzheimer's research, Lilly Canada announced Health Canada's ...

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Norgine welcomes TGA registration in Australia of Pedmarqsi (sodium thiosulphate anhydrous) for the prevention of cisplatin-induced hearing loss in children

6 May 2026 - Norgine is pleased to announce that Pedmarqsi (sodium thiosulphate anhydrous) has been registered by the Australian TGA ...

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FDA grants fast track designation for CS-1103, a first in class small molecule to reverse acute intoxication from fentanyl

5 May 2026 - Clear Scientific announced today that the US FDA has granted its lead asset, CS-1103, fast track designation ...

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Spinogenix receives US FDA fast track designation for tazbentetol for the treatment of ALS

5 May 2026 - Spinogenix today announced that the US FDA has granted fast track designation to tazbentetol for the ...

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Satellite Bio announces FDA rare paediatric disease designation for SB-101 for the treatment of urea cycle disorders

4 May 2026 - Satellite Biosciences today announced that the US FDA has granted rare paediatric disease designation for SB-101 for ...

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Expert says treatment relieves children's suffering and saves hospital resources

5 May 2026 - The family of an eight year old Sunshine Coast girl is petitioning the federal government to ...

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Atossa Therapeutics receives FDA rare paediatric disease designation for (Z)-endoxifen for McCune-Albright syndrome

4 May 2026 - Atossa Therapeutics today announced that the US FDA has granted rare paediatric disease designation to (Z)-endoxifen for ...

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'Tearing her skin apart': Sydney family among thousands priced out of life-changing medication

3 May 2026 - Jade Hlucshniow was on the brink of selling her home to afford treatment for her daughter, ...

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Korea covers Takeda’s Takhzyro, but most patients may still be left out: experts

26 March 2026 - Korea has granted reimbursement for Takeda’s hereditary angioedema drug Takhzyro (lanadelumab), but physicians say most patients ...

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New first in class therapy for chronic graft versus host disease approved in Australia

3 May 2026 -  Specialised Therapeutics is pleased to announce that Niktimvo (axatilimab) has been approved for use in Australia ...

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Affordable treatment for Australians with colorectal cancer

3 May 2026 - Australians with stage 4 colorectal cancer are among those who will benefit from new drug listings ...

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US pushes real time clinical trials to eliminate “dead time” in approvals

1 May 2026 - The US FDA is testing “real time clinical trials,” which it says will provide faster access ...

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Apotex becomes the first Canadian‑based pharmaceutical company to receive Health Canada approval for a generic equivalent of Ozempic

1 May 2026 - Apotex today announced that Health Canada has approved Apo‑Semaglutide Injection, a generic equivalent of Ozempic (semaglutide injection).  ...

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