Averoa receives European marketing authorisation for Xoanacyl, an oral therapy for chronic kidney disease

16 June 2025 - AVEROA actively seeking strategic partners and investors to bring Xoanacyl to European patients and unlock full ...

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Aquestive Therapeutics announces FDA acceptance of new drug application and PDUFA date for Anaphylm for the treatment of severe allergic reactions

16 June 2025 - FDA assigns PDUFA target action date of 31 January 2026 ...

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KalVista Pharmaceuticals announces FDA will not meet PDUFA goal date for sebetralstat NDA for hereditary angioedema due to FDA resource constraints

13 June 2025 - Agency indicates anticipated decision within four weeks ...

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EMA publishes agenda for 16-19 June 2025 CHMP meeting

16 June 2025 - The EMA has published a draft agenda for this week's CHMP meeting. ...

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Celltrion announces US FDA approval of additional presentation of Steqeyma (ustekinumab-stba), expanding dosing options for pediatric patients

15 June 2025 - Approval of 45 mg/0.5 mL solution in a single-dose vial for subcutaneous injection expands dosing flexibility for ...

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No drug price pledges by Pfizer, others in talks with US Government, Pfizer CEO says

9 June 2025 - Pfizer and other drug companies have met with the Trump administration to discuss lowering US drug ...

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Xediton Pharmaceuticals announced today the Canadian approval and availability of Vabomere (meropenem-vaborbactam) in Canada

12 June 2025 - Xediton Pharmaceuticals is proud to announce that Vabomere (meropenem-vaborbactam) has been approved by Health Canada and ...

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GSK’s RSV vaccine, Arexvy, accepted for regulatory review by the EMA to expand use in adults 18 years and older

13 June 2025 - Regulatory decision anticipated H1, 2026. ...

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Moderna receives US FDA approval for RSV vaccine, mRESVIA, in adults aged 18–59 at increased risk for RSV disease

12 June 2025 - Expanded indication builds on existing US FDA approval of mRESVIA for adults aged 60 and older. ...

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NICE leads the way in approving breakthrough treatment for multiple myeloma

13 June 2025 - People in England will become the first in the world to receive belantamab mafodotin for this indication ...

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AbbVie’s Epkinly, Eisai’s Lenvima pass reimbursement review; Janssen’s Tecvayli fails

11 June 2025 - AbbVie Korea's Epkinly (epcoritamab), a treatment for adults with relapsed or refractory diffuse large B-cell lymphoma ...

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UCB's new psoriasis biologic Bimzelx debuts in Korea with reimbursement

13 June 2025 - Belgium-based UCB's novel psoriasis therapy, Bimzelx (bimekizumab), has officially entered Korea's competitive plaque psoriasis market with ...

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FDA grants priority review for zoliflodacin new drug application for the treatment of uncomplicated gonorrhoea

12 June 2025 - Innoviva Specialty Therapeutics today announced that the US FDA has granted priority review for the new drug ...

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Sumitomo Pharma America announces that nuvisertib (TP-3654) has received FDA fast track designation for the treatment of myelofibrosis

12 June 2025 -  Nuvisertib (TP-3654), an investigational highly selective oral PIM1 kinase inhibitor, is being evaluated in patients with ...

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FDA approves neo-adjuvant and adjuvant pembrolizumab for resectable locally advanced head and neck squamous cell carcinoma

12 June 2025 - Today, the FDA approved pembrolizumab (Keytruda, Merck) for adults with resectable locally advanced head and neck ...

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FDA approves mitomycin intravesical solution for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer

12 June 2025 - Today, the FDA approved mitomycin intravesical solution (Zusduri, UroGen Pharma) for adult patients with recurrent low-grade ...

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