All US Food and Drug Administration (FDA) articles – Page 4
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NewsFDA approves innovative gene therapy for MLD
Following US FDA approval of Lenmeldy™ (atidarsagene autotemcel) for early-onset metachromatic leukodystrophy (MLD), the US wholesale acquisition cost of the gene therapy has been set to $4.25 million.
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NewsFDA approval could shape liver disease treatment landscape
A novel liver therapy authorised under US Food and Drug Administration (FDA) Accelerated Approval, is a potential game-changer in the NASH treatment space.
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NewsFDA warning letters highlight data integrity issues
Recent FDA Warning Letters have identified three manufacturers whose facilities held data integrity violations related to microbiology and environmental monitoring.
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NewsSandoz granted novel biosimilars approval
The approval authorises the interchangeability of denosumab biosimilars in the US to treat primary and secondary bone loss.
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NewsMedical device manufacturers must remain “vigilant” to ensure data integrity of premarket submissions
With the integrity of a greater number of third-party-generated data called into question, the US Food and Drug Administration (FDA) is unable to rely on the data to grant marketing authorisation, the agency asserts.
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ArticleDelivery systems for biologics
Designing systems for delivery of biologics is often a significant challenge during clinical development. Here, Dave Li, Edyta Działo and Anna Baran of KCR Consulting highlight the need for balancing safety, effectiveness, cost and reducing patient discomfort.
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ArticleForward-thinking CDMO tackles the dynamic challenge of N-nitrosamines control with high-performance analytical instrumentation
Poland-based Polpharma API relies on Waters analytical instrumentation for impurities method development and testing to meet the ever-evolving regulatory guidance around N-nitrosamines (nitrosamines) control in active pharmaceutical ingredients (API).
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Article2024 Pharmaceutical industry trends - discover the latest pharma quality and manufacturing trends
Some of the most sought-after human experiences are health and happiness. Although pharmaceutical companies cannot determine personal happiness, they are working to improve personal health outcomes that can tip the scale. The demand for personalised medicines, cell and gene therapies, hyperresponsive and patient-centric healthcare, real-world data fuelled by artificial intelligence ...
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NewsInnovation to drive advanced drug delivery market
The advanced drug delivery market is anticipated witness a compound annual growth rate (CAGR) of 4.6 percent by 2033, according to a report.
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NewsNovel immunotherapy approved for melanoma
The first non-CAR-T adoptive cell therapy to reach the market has been approved by the US Food and Drug Administration (FDA).
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NewsRevised ISO guideline highlights toxicological evaluation of extractables and leachables
Included in the revised ISO 10993-17 guideline are requirements for toxicological risk assessment of medical device constituents, such as extractables and leachables (E&L).
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ArticlePharmaceutical industry: 2023 in retrospect
In this article, Dave Elder delves deeper into some ongoing developments in topic areas highlighted in European Pharmaceutical Review (EPR) during 2023.
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NewsEosinophilic esophagitis medicine approval expanded
Approval of the first treatment for patients one year old and over with eosinophilic esophagitis (EoE) was based on trial data showing a greater proportion of children given Dupixent achieved histological remission compared to placebo.
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NewsFDA guidance highlights E&L considerations for ophthalmic drug products
In draft guidance on quality considerations for topical ophthalmic drug products, the US Food and Drug Administration (FDA) provided recommendations for E&L testing.
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NewsFDA grants priority review to omalizumab for food allergies
If approved, monoclonal antibody omalizumab would be the first medicine to reduce allergic reactions to multiple foods following an accidental exposure.
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ArticleYear in review: EPR’s top stories of 2023
EPR wraps up the year with a selection of top stories from 2023, highlighting key trends and topics such as environmental monitoring (EM), quality (QA/QC), manufacturing, regulation and clinical development.
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NewsGSK immuno-oncology treatment achieves novel EU approval
The EC’s approval of the immuno-oncology treatment “will define a new standard of care for certain patients with advanced or recurrent endometrial cancer in the EU,” says principal investigator of the RUBY trial.
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NewsNovartis secures first-of-a-kind haematology approval
A novel Factor B inhibitor of the immune system's complement pathway has been approved for paroxysmal nocturnal haemoglobinuria (PNH).
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NewsFirst pill for desmoid tumours approved
Approval of the first treatment option for desmoid tumours beyond surgery and radiation has been granted by the US Food and Drug Administration (FDA).
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NewsUSP General Chapter <660>—Glass revised
To create opportunity for glass innovation, the Packaging and Distribution Expert Committee (PD EC) revised the United States Pharmacopeia (USP) General Chapter —Glass.