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FDA investigates 'serious risk' of secondary cancer following CAR-T treatment

Fierce Pharma

In a blow to CAR-T therapies, the FDA is investigating a “serious risk” of patients developing new cancers after treatment with these highly efficacious oncology drugs. | In a blow to CAR-T therapies, the FDA is investigating a “serious risk” of patients developing new cancers after treatment with these highly efficacious oncology drugs.

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FDA approves bluebird's sickle cell disease gene therapy. Can Lyfgenia overcome CRISPR’s halo?

Fierce Pharma

Alongside a historic approval for the first therapy utilizing the Nobel Prize-winning CRISPR/Cas9 gene-editing technology, the FDA has cleared a rival gene replacement therapy, also for sickle cell | Alongside a historic approval for the first therapy utilizing the Nobel Prize-winning CRISPR/Cas9 gene-editing technology, the FDA has cleared a rival (..)

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Novartis hit with FDA letter detailing 'significant' Kymriah manufacturing shortfalls

Fierce Pharma

" But churning out these complex, individualized drugs has routinely tripped up even the industry's l | In recent months, Novartis has faced scrutiny from the FDA over Kymriah production shortfalls, a newly posted letter shows. When it comes to manufacturing cell therapies, it's often said that the "process is the product."

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FDA endorses Novartis' 'pipeline in a pill,' granting first nod for potential blockbuster Fabhalta

Fierce Pharma

With an FDA approval in PNH, Novartis has gained its first nod for iptacopan, dubbed two months ago “a pipeline in pill," by analysts at ODDO BHF.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

A recent draft from the FDA provides valuable insight. What will the future hold for clinical research?

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Vertex, CRISPR score landmark FDA approval for sickle cell disease gene therapy Casgevy

Fierce Pharma

Vertex Pharmaceuticals and CRISPR Therapeutics have won an historic FDA approval for their sickle cell disease gene therapy Casgevy. Groundbreaking? Game-changing? Transformational?

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Lawmakers want to know why it took the FDA so long to rule on decongestant phenylephrine

Fierce Pharma

House Republicans want to know why it has taken so long for the FDA to act on the decongestant phenylephrine. who chairs the House oversight subcommittee on health care and financial services, has sent a letter to FDA commissioner Robert Califf, requesting a briefing on the effectiveness of the over-the-counter drug by Dec.

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