All US Food and Drug Administration (FDA) articles
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NewsFDA revises PK study approach in new biosimilar draft guidance
Sandoz is also adjusting its global strategy by recruiting Armin Metzger as President of Biosimilar Development, Manufacturing & Supply.
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NewsVinay Prasad to exit CBER as FDA group director
US agency is set to see another new face take the helm, following Dr Prasad’s departure at the end of April.
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NewsFDA drafts new ultra-rare disease therapy guidance
Agency’s planned framework is the first to support the approval process for new ultra-rare disease treatments.
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NewsFDA policy sets new clinical trial requirements for drug approvals
The default standard would see US drug and biologic approvals require a single, robust pivotal study plus confirmatory evidence, instead of two trials.
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NewsFDA launches PreCheck pilot programme for US pharma manufacturers
The regulator’s new programme aims to create more efficient regulatory review processes for new pharmaceutical manufacturing facilities.
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NewsEMA and FDA issue joint AI guidance for medicine development
The regulators’ 10 principles aim to support pharma companies with evidence generation and monitoring for new medicines.
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NewsAI framework could enhance continuous manufacturing, say FDA researchers
Digital twin model offers potential for advanced control during continuous pharmaceutical manufacturing processes.
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NewsJ&J’s Rybrevant-Lazcluze combination wins FDA first in lung cancer
US approval of the subcutaneous therapy provides a novel chemotherapy-free frontline option in EGFR-mutated NSCLC.
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NewsImpurities findings could enhance peptide drug safety
EpiVax and Cubrc research supports FDA guidance on impurity risk assessment in generic peptides.
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NewsBristol Myers Squibb wins fifth US approval for CAR T cell therapy Breyanzi
The FDA’s latest authorisation makes it the most widely approved of any CD19-directed CAR T therapy in cancer.
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NewsFDA hits Sarepta with liver warning labelling for its DMD drug Elevidys
As well as the new safety warnings for the Duchenne muscular dystrophy gene therapy, the biopharma company also faced a new, more restrictive licence for the treatment.
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NewsFDA names Dr Richard Pazdur to replace George Tidmarsh as CDER Director
The FDA-veteran and oncology specialist will lead the US drug agency’s work ensuring the safety and efficacy of medicines.
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FDA draft guidance on biosimilars offers “regulatory relief”
US agency follows in footsteps of European Medicines Agency (EMA) in efforts to streamline biosimilar development.
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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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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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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.