FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease

29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...

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Amgen makes Repatha available though AmgenNow, a direct to patient program in the US

6 October 2025 - Eligible patients can access Repatha at nearly 60% discount from the list price. ...

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Why Pfizer’s Trump deal is good news for all of big pharma

2 October 2025 - The company’s accord with the president clears a cloud over the whole sector. ...

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Alzinova receives fast track designation from US FDA for ALZ-101 in Alzheimer’s disease

4 October 2025 - Alzinova today announces that the US FDA has granted fast track designation for the company’s vaccine candidate ...

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Andexanet alfa for haemorrhage: hope not fulfilled

1 October 2025 - A comparative study conducted at the instigation of the EMA shows only negative effects. ...

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Engaging stakeholders along health technology assessment pathways: a scoping review of international practice

30 September 2025 - Health technology assessment has been characterised as a complex adaptive system that centrally features stakeholder interactions.  ...

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Ensem Therapeutics announces ETX-636 granted fast track designation by the FDA for advanced breast cancer

1 October 2025 - Ensem Therapeutics today announced the US FDA granted fast track designation to its clinical stage pan mutant-specific ...

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Does big pharma gouge Americans?

2 October 2025 - In the bloated health care system, others are the real money makers. ...

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FDA approves Roche’s Tecentriq plus lurbinectedin as first-line maintenance therapy for extensive-stage small cell lung cancer

3 October 2025 - Regimen recommended in National Comprehensive Cancer Network Guidelines for small cell lung cancer. ...

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Alto Neuroscience receives FDA fast track designation for ALTO-101 for the treatment of cognitive impairment associated with schizophrenia

3 October 2025 - Alto Neuroscience today announced that the US FDA has granted fast track designation to ALTO-101 for the ...

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Bristol Myers Squibb plans to launch Cobenfy (xanomeline and trospium chloride) in the UK at a list price equal to the US launch price

22 September 2025 - Bristol Myers Squibb plans to launch Cobenfy (xanomeline and trospium chloride), in the UK in 2026.  ...

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Health Canada approves Agamree (vamorolone) as the first treatment for Duchenne muscular dystrophy in Canada

2 October 2025 - Kye Pharmaceuticals announced today that Health Canada has approved Agamree (vamorolone) for the treatment of Duchenne muscular ...

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Nacuity Pharmaceuticals granted US FDA breakthrough therapy designation for NPI-001 (N-acetylcysteine amide) tablets for the treatment of retinitis pigmentosa

2 October 2025 - Nacuity Pharmaceuticals today announced that the US FDA has granted breakthrough therapy designation to NPI-001 (N-acetylcysteine amide) ...

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FDA approves lurbinectedin in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs for extensive-stage small cell lung cancer

2 October 2025 - Today, the FDA approved lurbinectedin (Zepzelca, Jazz Pharmaceuticals) in combination with atezolizumab (Tecentriq) or atezolizumab and ...

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Taysha Gene Therapies announces FDA breakthrough therapy designation and provides positive regulatory update on TSHA-102 in Rett syndrome

2 October 2025 - Breakthrough therapy designation granted based on FDA’s review of available clinical evidence of safety and efficacy from ...

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Calico Life Sciences announces US FDA fast track designation for investigational treatment of autosomal dominant polycystic kidney disease

2 October 2025 - Calico Life Sciences today announced the US FDA granted fast track designation for ABBV-CLS-628, an investigational therapy ...

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