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tag food and drug administration evolution

Bugs as Drugs to Boost Cancer Therapy
Danielle Gerhard, PhD | Jan 18, 2024 | 7 min read
Bioengineered bacteria sneak past solid tumor defenses to guide CAR T cells’ attacks.
A needle drawing up fluid from an unlabeled vial.
Cancer Vaccination as a Promising New Treatment Against Tumors
Shelby Bradford, PhD | Mar 15, 2024 | 10+ min read
Vaccination has beaten back infections for more than a century. Now, it may be the next big step in battling cancer.
Cancer Researchers Use Evolution to Target Drug Resistance
Catherine Offord | Apr 1, 2020 | 10+ min read
New therapeutic approaches in oncology aim to manipulate or block cancer’s adaptation to treatment.
a photo of the packaging for the drug Trikafta
FDA Approves New Cystic Fibrosis Drug
Shawna Williams | Oct 24, 2019 | 1 min read
The treatment, Trikafta, increases lung function in most patients with the disease—but comes with a hefty price tag.
FDA Gives Nod to Melanoma Drug
Jef Akst | Sep 8, 2014 | 2 min read
The US Food and Drug Administration last week approved the first of a new type of immunotherapy that aims to pit a patient’s own immune system against her cancer.
Ebola Vaccine Approved for Use in Europe
Jef Akst | Nov 11, 2019 | 1 min read
Merck’s Ervebo gets its first regulatory greenlight. A decision from the US Food and Drug Administration is expected in the next few months.
Twist Bioscience and Biotia Receive U.S. FDA Emergency Use Authorization for First Hybridization Capture-Based Next-Generation Sequencing SARS-CoV-2 Assay
Twist Bioscience | Mar 29, 2021 | 3 min read
Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, and Biotia, Inc., a company that uses proprietary analytical software for infectious disease diagnostics, today received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the SARS-CoV-2 Next-Generation Sequencing (NGS) Assay.
FDA Eases Sterility Requirements
Bob Grant | May 16, 2012 | 1 min read
The US Food and Drug Administration has relaxed some of the rules governing how companies must test the sterility of materials used to make biologic drugs.
Adaptive Evolution
Alla Katsnelson | Aug 1, 2009 | 7 min read
By Alla Katsnelson Adaptive Evolution A once-rare type of clinical trial that violates one of the sacred tenets of trial design is taking off, but is it worth the risk? Doriano Solinas When researchers at Pfizer first began a Phase 2 trial of an acute stroke therapy in 2000, they decided to take a novel approach. The study—called the ASTIN trial—would determine the drug’s optimal dose not with three or four diffe
Research laboratory, no people, clean white, horizontal
Making Sense of Regulations
Cytiva | Feb 23, 2023 | 3 min read
Knowing what to focus on, what resources are available, and who to talk to for regulatory advice ahead of time can smooth the drug discovery journey.

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