All US Food and Drug Administration (FDA) articles – Page 2
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News
FDA to pilot faster review of generic drugs manufactured in the US
Sets bioequivalence and active pharmaceutical ingredient (API) requirements for its new ANDA prioritisation programme.
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News
FDA to modernise review process for developers of ultra-rare diseases
The regulator’s new principles aim to ease the pathway to regulatory approval for rare disease drug developers in the US.
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NewsFDA waives trial requirement for Stelera biosimilar, easing the copycat’s path
First-of-its-kind case continues EMA and MHRA harmonisation, streamlining the global biosimilar approval pathway.
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NewsFDA tightens use of Pfizer, Moderna and Novavax COVID-19 vaccines
RFK Jr hits Comirnaty, Spikevax and Nuvaxovid with revised approvals for ‘high risk’ individuals.
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News
FDA starts publishing daily adverse event data
US regulator says the move to open up the FAERS database will help modernise its safety monitoring.
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NewsVinay Prasad returns to lead vaccines and cell and gene therapy at the FDA
CBER head makes surprise comeback just weeks after his abrupt resignation.
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Article
Amid FDA turmoil Sarepta’s gene therapy worries begin to ease
But the impact of George Tidmarsh’s CBER appointment after Vinay Prasad’s abrupt resignation remains to be seen.
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NewsRegulatory shift signals potential change for future CGT sector
The cell and gene therapy (CGT) sector must maintain its scientific rigor despite recent changes to US policy and market conditions, says key industry body.
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ArticleThe rise of multimodal language models in drug development
Industry experts, Remco Jan Geukes Foppen, Vincenzo Gioia, Alessio Zoccoli and Carlos Velez reflect on the necessity to ensure data quality in order to gain full advantage from multimodal language models (MLMs).
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NewsFDA grants expanded approval for hepatitis drug
The FDA’s authorisation helps to address the “significant” remaining need for acute hepatitis C treatments, according to AbbVie.
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NewsFDA approves first-of-a-kind gene therapy for dystrophic epidermolysis bullosa
With clinical data showing the gene therapy can address large and challenging chronic wounds, the FDA’s decision will help improve quality of life for dystrophic epidermolysis bullosa (DEB) patients.
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ArticleQbD for biopharmaceutical product lifecycle management
Youngsun Kim and Busol Park from Samsung Biologics detail the benefits of using a Quality-by-design approach for biologics manufacturing.
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ArticleThe key role of GMP analytical testing for drug products
Ensuring the quality, safety and efficacy of new pharmaceutical products is critical to bring them to market successfully. Here, Adragos Pharma’s Amalia Stroumpou, explains how the key to all three of these factors is rigorous good manufacturing practice (GMP) analytical testing.
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OpinionAI in pharmaceutical development: hype or panacea?
Dave Elder reflects on the array of applications for AI to facilitate successful drug development, though proof remains elusive.
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NewsFDA approves first-in-class oral antibiotic
The drug is the first in a new class of oral antibiotics for uncomplicated urinary tract infections in nearly three decades.
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NewsFDA sends warning letter to KVK-Tech manufacturing facility
A warning letter has been sent by the US FDA to KVK-Tech regarding cGMP violations at their drug manufacturing site, including for data integrity.
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NewsFDA issues first recommendations on AI for drug development
The new US Food and Drug Administration (FDA) guidance will enhance credibility of AI models in drug and biological product regulatory submissions.
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ArticleEasing the mental health burden with psychedelic therapies – what’s next for the regulatory and clinical landscape?
In this article, Steffanie Wilson, Vice President and Neuroscience Therapeutic Area Lead, Emmes Group, discusses the future of psychedelic research and highlights the impact of the FDA’s decision on Lykos Therapeutics’ NDA for its MDMA therapy to treat PTSD.
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ArticleDeveloping donanemab - balancing cost versus benefit
This article summarises recent regulatory developments surrounding the Alzheimer’s treatment donanemab and considers the future therapeutic market for this disease.
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NewsHaemophilia treatment with new delivery method approved
The US FDA has authorised the first treatment for haemophilia A or B that is administered via a pre-filled pen or syringe.