All US Food and Drug Administration (FDA) articles
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NewsFDA warning letters highlight contamination control and facility maintenance failures
Findings from sterile drug manufacturing sites emphasise the agency’s expectation for companies to provide tangible evidence showing reduced quality and microbial risk and maintenance of control.
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NewsFDA approves MSD’s Lipfendra as first oral PCSK9 inhibitor
Regulatory win facilitates the growing market demand for peptide therapeutics.
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NewsFDA presents route to improve operational efficiency of drug manufacturing
Proposal aims to modernise registration for distributed drug manufacturers, strengthening real-time transparency across the pharmaceutical supply chain.
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NewsUS approval of Orca’s Tregzi landmark advance for stem cell transplants
FDA’s authorisation based on data showing the precision-engineered cell therapy improved survival free of GVHD in adults with haematological malignancies.
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NewsGenentech’s Xofluza approved as first single-dose generic for influenza in US
FDA’s approval of generic baloxavir marboxil tablets for influenza broads access to a novel-mechanism antiviral for individuals aged five years and over.
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NewsFDA approves first-in-class aldosterone synthase inhibitor for uncontrolled hypertension
The US FDA has approved Baxfendy (baxdrostat), the first aldosterone synthase inhibitor for hypertension, offering a novel mechanism for approximately 23 million US patients whose blood pressure remains uncontrolled despite multiple medications.
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NewsMakary resigns as commissioner of US FDA
The resignation adds to staffing pressure as the US medicines regulator navigates continuing challenges.
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NewsFDA refines strategy with one-day inspectional assessment pilot
Initiative shown to enhance agency’s efficacy by increasing the number of facilities it can assess, without comprising regulatory rigour.
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NewsFDA marks progress in implementing real-time clinical trials
Advances agency’s goal in facilitating continuous trials, aimed at accelerating promising therapies.
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NewsFDA approves Breztri as first triple-therapy inhaler for asthma
AstraZeneca’s Breztri Aerosphere has become the first fixed-dose triple-combination inhaler approved by the FDA for asthma maintenance treatment in adults and adolescents aged 12 and older, addressing unmet needs for approximately 13.5 million US patients uncontrolled on dual therapies.
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NewsOtarmeni Regeneron’s first genetic medicine to gain approval
Authorisation of the AAV gene therapy in the US marks a milestone for treating genetic hearing loss.
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NewsNew FDA draft guidance to enhance safety of genome editing therapies
Recommendations support next-generation sequencing-based safety evaluation of off-target editing for personalised gene therapies.
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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.