Bayer files for approval of finerenone in heart failure in the EU

3 February 2025 - Regulatory submission is based on positive data from the Phase 3 FINEARTS-HF study presented at ESC Congress ...

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Brentuximab vedotin in combination with chemotherapy for the treatment of patients with stage 3 or 4 CD30 positive Hodgkin lymphoma

7 May 2025 - Brentuximab vedotin, when used in combination with doxorubicin hydrochloride, dacarbazine and vinblastine sulphate is recommended as an ...

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MHRA approves teprotumumab as the first UK treatment for adults with moderate to severe thyroid eye disease

7 May 2025 - The MHRA has today approved teprotumumab (Tepezza).  ...

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European Commission approves Tremfya (guselkumab), the first dual-acting IL-23 inhibitor offering both subcutaneous and intravenous induction options, for adult patients with moderately to severely active Crohn's disease

7 May 2025 - Data from the pooled GALAXI 2 and 3 studies showed that guselkumab demonstrated greater efficacy compared to ...

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Lilly, Novo Nordisk seek insurance coverage in Korea for diabetes drugs Mounjaro and Ozempic

2 May 2025 - In Korea, Eli Lilly and Novo Nordisk are pushing for national health insurance coverage for their ...

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Patient group urges quick reimbursement of Besremi for polycythemia vera

7 May 2025 - The Korea Leukemia Patients Organization has called for the reimbursement of Besremi (ropeginterferon alfa-2b), the only ...

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Adcentrx Therapeutics granted fast track designation for ADRX-0706 nectin-4 antibody drug conjugate for the treatment of advanced cervical cancer

6 May 2025 - Adcentrx Therapeutics today announced that the US FDA has granted fast track designation to its lead ...

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Viridian Therapeutics receives FDA breakthrough therapy designation for veligrotug for the treatment of thyroid eye disease

7 May 2025 - Biologics license application submission for veligrotug on track for second half 2025 with a planned US ...

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ImmunityBio requests an urgent meeting with FDA to address the change in the Agency’s unambiguous guidance on Jan 2025 to submit a sBLA for NMIBC BCG unresponsive papillary disease, following an inconsistent refusal to file letter on 2 May 2025

5 May 2025 - ImmunityBio today announced that the Company received a refusal to file letter from the US FDA for ...

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Omaveloxolone for the treatment of patients with Friedreich’s ataxia

6 May 2025 - NICE is unable to make a recommendation on the use of omaveloxolone (Skyclarys) for the treatment of ...

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FDA accepts resubmission of BLA for narsoplimab for haematopoietic stem cell transplant-associated thrombotic microangiopathy and assigns late September PDUFA date

6 May 2025 - Omeros Corporation today announced that the US FDA has accepted for review the resubmission of the biologics ...

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Italfarmaco announces US FDA grants fast track designation to givinostat in treatment of polycythemia vera

6 May 2025 - Italfarmaco announced today that the US FDA has granted fast track designation to givinostat for the ...

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Health Canada has granted approval for Tzield, the first and only disease-modifying therapy in auto-immune type 1 diabetes in Canada

5 May 2025 - Tzield is demonstrated to delay by a median of 2 years the onset of Stage 3 type ...

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Calquence plus chemoimmunotherapy approved in the EU as first and only BTK inhibitor for first-line mantle cell lymphoma

6 May 2025 - Approval based on ECHO Phase III trial results which demonstrated over 16 months of progression-free survival ...

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Rezolute receives breakthrough therapy designation from FDA for ersodetug in the treatment of hypoglycaemia due to tumour hyperinsulinism

5 May 2025 - Registrational study in patients with tumour hyperinsulinism expected to commence mid-year. ...

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Ichnos Glenmark Innovation receives US FDA fast track designation for ISB 2001 for relapsed/refractory multiple myeloma

5 May 2025 - IGI, today announced that the US FDA has granted fast track designation for ISB 2001.  ...

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