FDA Advisory Committee Panel strongly recommends approval of Shield blood test for colorectal cancer screening as a primary non-invasive screening option

23 May 2024 - Shield remains on track to become the first FDA approved blood test that meets performance requirements for ...

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Celltrion receives European Commission approval of Omlyclo (CT-P39), the first and only omalizumab biosimilar approved in Europe

23 May 2024 - The European Commission decision is based on clinical evidence, including results from a Phase 3 clinical trial ...

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Antengene's Xpovio moves close to getting insurance benefits

3 May 2024 - Xpovio (selinexor), the first drug launched in Korea by Antengene, has won recognition to receive reimbursement ...

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Setmelanotide acetate for the treatment of patients with obesity and hyperphagia in Bardet-Biedl syndrome (final guidance)

22 May 2024 - NICE has published final evidence-based recommendations on the use of setmelanotide acetate (Imcivree) for treating obesity ...

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Health Canada approves Cosentyx, a biologic therapy, for the treatment of adults with moderate to severe hidradenitis suppurativa

22 May 2024 - Approval is based on the two largest Phase 3 trials conducted in hidradenitis suppurativa – SUNSHINE and SUNRISE ...

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Sandoz receives European Commission approval for Wyost and Jubbonti, the first and only biosimilars of denosumab in Europe

22 May 2024 - EC approval based on robust development program confirming that biosimilar matches reference medicine in terms of ...

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Sirolimus for the treatment of patients with facial angiofibroma caused by tuberous sclerosis complex

22 May 2024 - NICE is unable to make a recommendation on the use of sirolimus (Hyftor) for the treatment of ...

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FDA approves first interchangeable biosimilars to Eylea to treat macular degeneration and other eye conditions

20 May 2024 - Today, FDA approved Yesafili (aflibercept-jbvf) and Opuviz (aflibercecpt-yszy) as the first interchangeable biosimilars to Eylea (aflibercept). ...

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FDA withdraws accelerated approval to infigratinib for metastatic cholangiocarcinoma

16 May 2024 - Today, the FDA announced the final withdrawal of the approval of infigratinib (Truseltiq) for previously treated, ...

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HLB shares plummet following FDA rejection of liver cancer drug approval

17 May 2024 - HLB revealed that its US subsidiary, Elevar Therapeutics, and their Chinese partner, Jiangsu Hengrui Pharmaceuticals, received ...

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Health Canada approves Saladax’s 5-fluorouracil chemotherapy therapeutic drug monitoring test

14 May 2024 - Saladax Biomedical is pleased to announce that Health Canada has approved Saladax’s 5-Fluorouracil (My5-FU) Assay for sale ...

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Tisagenlecleucel for the treatment of patients with relapsed or refractory B-cell acute lymphoblastic leukaemia

15 May 2024 - NICE has published final evidence-based recommendations on the use of tisagenlecleucel (Kymriah) for the treatment of ...

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Selinexor in combination with bortezomib and dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma (final guidance)

15 May 2024 - NICE has published final evidence-based recommendations on the use of selinexor (Nexpovio) in combination with bortezomib ...

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Dynavax provides regulatory update on sBLA for four dose Heplisav-B regimen for adults on haemodialysis in the US

14 May 2024 - Dynavax Technologies today provided a regulatory update for the Company's supplemental biologics license application to include ...

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Atogepant monohydrate for the prevention of migraine

15 May 2024 - NICE has published final evidence-based recommendations on atogepant monohydrate (Aquipta) for preventing migraine in adults. ...

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