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tag business fda disease medicine regulation

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 Cracks Down on Purveyors of Stem Cell Treatments
Ashley P. Taylor | Dec 21, 2018 | 3 min read
The agency cites safety concerns with customers of Genetech who reported getting E. coli infections and sends letters to other stem cell companies reminding them to follow the rules.
A gloved hand holds a tweezer and pulls a section of DNA away from a double helix
First Person Dosed in Novel Gene Editing Clinical Trial
Amanda Heidt | Jul 12, 2022 | 4 min read
The biotech company Verve Therapeutics launched the study with the aim of using base editing to treat a genetic condition that causes high cholesterol and increases a person's risk of developing cardiovascular disease.
Four glass vials sit on a reflective tabletop next to a syringe. Each is labeled as a subsequent dose in a four-dose series of COVID-19 vaccines.
What We Know About Getting a Second Booster Shot of COVID-19 Vaccines
Dan Robitzski | Aug 11, 2022 | 10+ min read
Studies show that a fourth mRNA vaccine dose offers the elderly and other high-risk groups strong protection against hospitalization and death from COVID-19, but experts say benefits for other populations may be more limited.
A 3D rendering of a neuron
Independent FDA Advisory Panel Recommends Approving ALS Drug
Amanda Heidt | Sep 8, 2022 | 4 min read
The group’s 7-2 ruling in favor of the therapeutic represents a shift from previous deliberations, in which data on its effectiveness was deemed insufficient.
Updated Mar 8
A healthcare worker holds up three syringes with clear medicine
To Booster or Not: Scientists and Regulators Debate
Jef Akst | Sep 16, 2021 | 7 min read
President Biden’s planned rollout of additional COVID-19 vaccine doses is set to begin next week, but questions remain about who should get them.
MyHeritage Launches Health-Related Genetic Test, Ignites Debate
Catherine Offord | Jul 9, 2019 | 8 min read
Its screen for selected variants of some disease-linked genes gives customers an incomplete picture of their risk—do they know?
FDA Gets Into the Lab Test Game
Bob Grant | Aug 4, 2014 | 2 min read
So-called laboratory-developed tests will eventually face regulations similar to those that currently govern diagnostic tests or kits that are sold to hospitals.
A rendering of a human brain in blue on a dark background with blue and white lines surrounding the brain to represent the construction of new connections in the brain.
Defying Dogma: Decentralized Translation in Neurons
Danielle Gerhard, PhD | Sep 8, 2023 | 10+ min read
To understand how memories are formed and maintained, neuroscientists travel far beyond the cell body in search of answers.
Alternative Medicines
The Scientist | Jul 1, 2012 | 10+ min read
As nonconventional medical treatments become increasingly mainstream, we take a look at the science behind some of the most popular.

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