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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Duvelisib for patients with chronic lymphocytic leukaemia

27 July 2022 - NICE has published a final technology appraisal for duvelisib for the treatment of patients with relapsed ...

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EMA response to the monkeypox public health emergency

27 July 2022 - The EMA has initiated a series of actions to respond to the ongoing monkeypox outbreak, which ...

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‘No magic bullet’: For drug makers and the FDA, clinical trials on ultra rare diseases pose thorny challenges

26 July 2022 - Walker Burger is beside himself with worry. ...

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Henlius Hanquyou received TGA approval in Australia

26 July 2022 - Shanghai Henlius Biotech announced that the company's business partner Cipla has received the relevant registration certificates from ...

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Lowest drug plan premium does not always mean lowest cost for you

26 July 2022 - Before Medicare, you probably had coverage through an employer group health plan.  ...

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45 medicines affected by supply issues as COVID causes 'unprecedented challenge'

27 July 2022 - In the past month,  New Zealand has been hit by medicine supply issues affecting large swathes ...

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Novavax announces expanded approval of Nuvaxovid COVID-19 vaccine for adolescents aged 12 through 17 in Japan

26 July 2022 - Nuvaxovid is the first protein-based COVID-19 vaccine approved for use in adolescents in Japan. ...

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Ionis announces that FDA accepts new drug application and grants priority review of tofersen for a rare, genetic form of ALS

26 July 2022 - 12 month data included in the filing show that earlier initiation of tofersen slowed decline across measures ...

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Despite their anger over high drug prices, Americans are giving pharma credit for helping contain COVID-19

26 July 2022 - Nearly three quarters of Americans give the pharmaceutical industry credit for helping contain COVID-19 — and for ...

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LFB announces the approval of Cevenfacta (eptacog beta) in the European Union

25 July 2022 - The first new bypassing agent approved in the European Union for the treatment and control of bleeding ...

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The FDA needs to get ready to evaluate synthetic cells, the next generation of therapeutics

26 July 2022 - Expanding new medical treatments requires pushing — and sometimes breaking — the boundaries of what currently ...

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MHRA grants marketing authorisation for GBT’s Oxbryta (voxelotor) for use in Great Britain for the treatment of haemolytic anaemia in patients with sickle cell disease age 12 years and older

26 July 2022 - Voxelotor is the first medicine approved in Great Britain to directly inhibit sickle haemoglobin polymerisation, the underlying ...

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ERC granted FDA fast track designation for sitoiganap in patients with recurrent glioblastoma

26 July 2022 - ERC Belgium today announced that the U.S. FDA has granted fast track designation to Sitoiganap (Gliovac or ...

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European Commission approves Rinvoq (upadacitinib) for the treatment of adults with moderate to severe ulcerative colitis

26 July 2022 - The approval is based on the results of three Phase 3 studies: two for induction and one ...

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TGA gives a tick to Scemblix

26 July 2022 - Asciminib is an oral and potent inhibitor of Abelson non-receptor tyrosine kinases/breakpoint cluster region (ABL/BCR): ABL1 tyrosine ...

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