All US Food and Drug Administration (FDA) articles – Page 3
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NewsFirst-in-class telomerase inhibitor approved for blood cancer
The FDA’s regulatory approval of the telomerase inhibitor is welcome, considering the high unmet need for many lower-risk myelodysplastic syndromes (LR-MDS) patients, according to Geron.
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NewsTwo novel biosimilars approved in EU and US
The first omalizumab biosimilar in allergic diseases is approved by the European Commission and the US Food and Drug Administration (FDA) has authorised the fifty third biosimilar in the US.
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NewsEuropean authorities recognised for leading medicine regulatory oversight
Expansion of the WLA framework means that the largest number of regulatory agencies for medical products are approved as WHO Listed Authorities.
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NewsFDA approves Amgen T-cell engager for small cell lung cancer
Amgen’s Imdelltra™, previously known as tarlatamab, is approved for the treatment of adult patients with advanced small cell lung cancer.
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ArticleInsights into AstraZeneca’s MANDARA Phase III data
In this Q&A, Dr Michael Wechsler, Professor of Medicine, Director of the National Jewish Health (NJH)/Cohen Family Asthma Institute, reveals details of the data from the MANDARA Phase III trial, showing remission is achievable in EGPA with Fasenra.
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NewsUS agencies collaborate to address regulation for biotechnology products
In formulating the current Coordinated Framework for the Regulation of Biotechnology, the US Food and Drug Administration (FDA), US Environmental Protection Agency (EPA) and the US Department of Agriculture (USDA) utilised horizon scanning for novel biotechnology products.
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ArticleFrom viral vectors to nucleic acids: biopharma’s evolving manufacturing landscape
In this interview, Vikas Gupta, President of CDMO ReciBioPharm, outlines several key trends shaping the biopharma manufacturing landscape, including the rise of nucleic acid-based therapeutics, and the quest for continuous manufacturing.
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NewsNovel haemophilia B gene therapy approved
Pfizer has attained its first approval for a gene therapy from the US Food and Drug Administration (FDA), which is indicated to treat the rare blood disorder haemophilia B.
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NewsGenentech oncology treatment granted first-of-a-kind approval
The novel approval provides a dedicated therapy option for patients with ALK-positive early-stage lung cancer.
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NewsInnovative personalised immunotherapy approved for multiple myeloma
Approval of the cell therapy by the US FDA could provide a treatment-free respite as early as first relapse for patients with multiple myeloma.
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OpinionClinical trials for rare diseases
In this interview, Mindy Leffler, Managing Director of Qualitative Research and Psychometrics at Emmes Endpoint Solutions, discusses the nuances of designing clinical trials for rare diseases including specific challenges related to traditional endpoints.
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NewsFirst-in-class biologic approved for rare lung disease
The biologic therapy offers a novel therapeutic option that targets a new treatment pathway in pulmonary arterial hypertension (PAH).
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ArticleProcess analytics for the new era of continuous RNA manufacturing
In this article, Edita Botonjic-Sehic, Head of Process Analytics and Data Science at ReciBioPharm, examines the need for a digitally controlled continuous manufacturing process to correct the shortcomings of the current standard of batch processing. She highlights the critical role in-line process analytic technologies (PAT), automation and real-time data analytics ...
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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).