New treatment against Duchenne muscular dystrophy

25 April 2025 - Duvyzat can be used in a wide patient population from the age of six. ...

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First treatment against severe thyroid eye disease

25 April 2025 - Tepezza significantly improves symptoms for patients with moderate to severe thyroid eye disease ...

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Recommendations made by the PBAC – March 2025

24 April 2025 - Recommendations made by the PBAC in March 2025 relating to the listing of medicines on the PBS ...

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MHRA approves first UK treatment for Friedreich’s ataxia, omaveloxolone

23 April 2025 - The MHRA) has today approved omaveloxolone (Skyclarys), the first treatment for patients aged 16 and over, in ...

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Acoramidis approved to treat wild-type or variant transthyretin amyloidosis in adults with cardiomyopathy

25 April 2025 - The MHRA has approved the medicine acoramidis (Beyonttra) to treat adult patients with cardiomyopathy caused by ...

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Tremfya (guselkumab) receives European Commission approval for adults with moderately to severely active ulcerative colitis, strengthening Johnson & Johnson’s leadership in inflammatory bowel disease

25 April 2025 - Johnson & Johnson today announced that the European Commission has approved a Marketing Authorisation for Tremfya (guselkumab) ...

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CHMP recommends approval of Oczyesa for treatment of acromegaly in the EU

25 April 2025 - Camurus today announced that the EMA's CHMP has adopted a positive opinion for market authorisation of Oczyesa, ...

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Multiple myeloma drug subsidised after treatment costs ballooned

24 April 2025 - It’s one of the few cancers still considered incurable, and those diagnosed with multiple myeloma will likely ...

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FDA approves penpulimab-kcqx for non-keratinizing nasopharyngeal carcinoma

23 April 2025 - Today, the FDA approved penpulimab-kcqx (Akeso Biopharma) with cisplatin or carboplatin and gemcitabine for the first-line ...

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Sarclisa approved in Canada for patients with newly diagnosed multiple myeloma

22 April 2025 - This is the third indication for Sarclisa in Canada for the treatment of multiple myeloma. ...

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Marstacimab approved to treat patients aged 12 years and above (weighing at least 35 kg) with haemophilia A or B

22 April 2025 - The MHRA has approved the medicine marstacimab (Hympavzi) to prevent or reduce bleeding in patients 12 years ...

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Health Canada approves Keytruda plus pemetrexed and platinum chemotherapy as first-line treatment for adult patients with unresectable advanced or metastatic malignant pleural mesothelioma

22 April 2025 - Approval is based on the results from the Phase 3 CCTG IND.227/KEYNOTE-483 trial. ...

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Dupixent (dupilumab) approved in the US as the first new targeted therapy in over a decade for chronic spontaneous urticaria

18 April 2025 - Approval based on Phase 3 trials demonstrating Dupixent significantly reduced itch and hives compared to placebo. ...

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Health Canada expands Jemperli (dostarlimab for injection) plus chemotherapy approval to all adult patients with primary advanced or first recurrent endometrial cancer, as the first and only immuno-oncology-based treatment to show an overall survival benefit for these patients

17 April 2025 - Approval based on RUBY Part 1 trial, where Jemperli plus chemotherapy demonstrated a statistically significant and ...

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Neurelis announces FDA approval for immediate use seizure medication Valtoco (diazepam nasal spray) in age 2 to 5

16 April 2025 - Valtoco maintains orphan drug exclusivity for Valtoco to treat episodes of frequent seizures. ...

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