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CHMP adopts a positive opinion for change to the terms of the marketing authorisation for Paxlovid – Pfizer

Written by | 30 Nov 2025

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for Paxlovid (nirmatrelvir + ritonavir)…. read more.

Xtandi (enzalutamide) plus leuprolide reduced risk of death by 40% vs leuprolide alone in men with a type of advanced prostate cancer – Pfizer

Written by | 3 Nov 2025

Pfizer Inc and Astellas announced final overall survival (OS) results from the Phase III EMBARK study evaluating Xtandi (enzalutamide), in combination with leuprolide and as monotherapy, in men with… read more.

FDA approves Adcetris (brentuximab vedotin) combination regimen for the treatment of relapsed/refractory diffuse large B-cell lymphoma – Pfizer

Written by | 11 Aug 2025

Pfizer Inc. announced  that the FDA has approved the supplemental Biologics License Application (sBLA) for Adcetris (brentuximab vedotin) in combination with lenalidomide and a rituximab product for the… read more.

Ngenla (somatrogon) withdrawal of application for variation to marketing authorisation for growth hormone deficiency – Pfizer

Written by | 2 Aug 2025

The EMA revealed that Pfizer had withdrawn its application submitted on December 20, 2024, for variation to the marketing authorisation for Ngenla to treat adults with growth hormone… read more.

Positive CHMP opinion for Bosulif (bosutinib) on variation to marketing authorisation to extend the use of Bosulif to children aged 6 years and older – Pfizer

Written by | 11 Jul 2025

The Committee for Medicinal Products for Human Use (CHMP) of the EMA adopted a positive opinion, recommending a change to the terms of the marketing authorisation for Bosulif…. read more.

NICE (UK) update for Paxlovid (nirmatrelvir plus ritonavir, sotrovimab and tocilizumab) for treating COVID-19 – Pfizer

Written by | 29 Jun 2025

NICE (UK) Nirmatrelvir plus ritonavir is recommended as an option for treating COVID‑19 in adults, only if they: i) do not need supplemental oxygen for COVID‑19 and, ii)… read more.

ACIP votes to expand recommendation for RSV vaccine Abrysvo, to include adults aged 50 to 59 at increased risk of disease – Pfizer

Written by | 15 Jun 2025

Pfizer Inc. announced that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to expand its recommendation for the use of… read more.

MHRA (UK) approves Hympavzi (marstacimab) to treat haemophilia A or B in adult and paediatric patients – Pfizer

Written by | 30 May 2025

Hympavzi (marstacimab) from Pfizer has been approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA) to treat haemophilia A or B in adult and paediatric patients…. read more.

FDA accepts application for BLA for MenABCWY vaccine for meningococcal disease – Pfizer

Written by | 1 May 2025

Pfizer announced that the FDA accepted for review a Biologics License Application (BLA) for MenABCWY, its investigational pentavalent meningococcal vaccine candidate. Pfizer submitted MenABCWY for the prevention of… read more.

Pfizer highlights progress in Oncology with over 60 presentations at ASCO 2025

Written by | 27 Apr 2025

Pfizer Inc will showcase data across its portfolio of potential breakthrough cancer medicines at the 2025 American Society of Clinical Oncology (ASCO®) Annual Meeting, taking place May 30… read more.

European Commission approves RSV vaccine Abrysvo to help protect adults aged 18-59 against RSV lower respiratory tract disease – Pfizer

Written by | 15 Apr 2025

Pfizer Inc.  announced that the European Commission (EC) has issued a decision amending the marketing authorization for  Abrysvo the company’s bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF)… read more.

Talzenna (talazoparib) in combination with Xtandi (enzalutamide) improves survival outcomes in metastatic castration-resistant prostate cancer – Pfizer

Written by | 31 Mar 2025

Pfizer Inc. announced positive results from the Phase III TALAPRO-2 study of Talzenna, an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with Xtandi (enzalutamide), an androgen receptor… read more.

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