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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Better care and treatment for Australians with blood cancer

15 March 2022 - Australians with blood cancer will receive improved treatment and care through new and continued funding from the ...

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Hansa Biopharma and German payer head association agree on reimbursement price for Idefirix (imlifidase) as desensitisation treatment for highly sensitised kidney transplant patients

15 March 2022 - Hansa Biopharma completes the AMNOG reimbursement process for Idefirix in Germany. ...

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FDA approves first generic of Symbicort to treat asthma and COPD

15 March 2022 - Agency supports development of complex generic drug-device combination product to improve competition and access to more affordable ...

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Prolonged price negotiation for Kymriah devastates leukaemia patients

15 March 2022 - Drained by dragging price negotiations between Novartis and the Government for breakthrough cancer treatment Kymriah (tisagenlecleucel), ...

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BeiGene and Medison announce approval and national reimbursement in Israel for Brukinsa (zanubrutinib) for the treatment of Waldenström's macroglobulinaemia

15 March 2022 - Second regulatory approval for Brukinsa in Israel. ...

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What’s really driving drug costs?

15 March 2022 - Despite the wonders accomplished by the biopharmaceutical industry in providing us vaccines and therapeutants to get us ...

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Myrtelle receives FDA fast track, rare paediatric disease, and orphan drug designations for its proprietary gene therapy for the treatment of Canavan disease

15 March 2022 - Myrtelle today announced that the U.S. FDA has granted fast track, rare paediatric disease and orphan ...

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Drug industry says EMA’s PRIME scheme useful but could be improved

14 March 2022 - Eligibility criteria for admission to the EMA's priority medicines (PRIME) scheme are too strict to facilitate ...

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Single dose Kozenis (tafenoquine) approved for children with Plasmodium vivax malaria by Australian Therapeutic Goods Administration

14 March 2022 - Novel paediatric relapse prevention treatment marks a major contribution towards malaria elimination efforts. ...

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Collider bias

14 March 2022 - Bias is a systematic, non-random error in the estimation of a treatment effect or the effect of ...

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1 April 2022 price disclosure confirmed prices

15 March 2022 - Confirmed 1 April 2022 prices resulting from the 2022 April cycle of price disclosure have now been ...

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Teduglutide for treating short bowel syndrome

11 March 2022 - The Department of Health and Social Care has asked NICE to produce guidance on using teduglutide ...

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Imlifidase for preventing kidney transplant rejection in people with chronic kidney disease

11 March 2022 - The Department of Health and Social Care has asked NICE to produce guidance on using imlifidase ...

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Incyte announces U.S. FDA has extended the supplemental new drug application review period for ruxolitinib cream (Opzelura) for the treatment of vitiligo

14 March 2022 - Incyte announced today that the U.S. FDA has extended the review period for the supplemental new ...

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Corium receives FDA approval of Adlarity (donepezil transdermal system) for treatment of patients with Alzheimer's disease

14 March 2022 - First and only once weekly patch for convenient, well-tolerated delivery of most used drug for treatment of ...

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