Tag: U.S. Food and Drug Administration
New Alzheimer’s Drug Approval Could Change the FDA’s Approval Process for the Better
After the experimental treatment for Alzheimer’s named aducanumab failed a futility test, its producers Biogen and Eisai lost hope the Food and Drug Administration would ever approve it. Despite promising clinical results through the approval process, the producers abandoned their project in 2019.  Eight months later, Biogen developed an expanded dataset to reassess aducanumab’s impact...
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AstraZeneca Vaccine Controversy Provides Another Example of Overly Cautious Government Reactions
After a sluggish and error-prone beginning to a country-wide effort to vaccinate Americans against Covid-19, it seems things are quickly improving. According to the Centers for Disease Control, as of March 18th, nearly 113 million Americans have received at least Covid-19 vaccination (two of the three available vaccines require two separate injections). The agency...
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New COVID-19 Vaccines, Same Sluggish FDA
In October, large portions of the United States began experiencing rapid increases in new COVID-19 cases. Many European countries have experienced a similar surge in cases, even after being devastated by severe COVID-19 outbreaks earlier this year. Fearing the arrival of a second wave, several states reenacted various lockdown measures to curb spreading disease....
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FDA Acknowledges Coronavirus Is Causing More Drug Shortages
The first outbreak of the coronavirus occurred in China nearly two months ago. The disease quickly spread through the country. As of March 5th, the coronavirus is responsible for over 80,000 confirmed cases and nearly 3,400 deaths across China. Globally over 98,000 people are infected, resulting in nearly 4,000 deaths. At this time, the...
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FDA’s Approval of Generic Daraprim Offers Lessons on Drugs Prices
In 2015, Turning Pharmaceuticals CEO Martin Shkreli increased the price of the drug Daraprim nearly 5,000 percent from $13.50 to $750 per pill. The price hike generated widespread outrage, earning Shkreli the moniker “Pharma Boy” and the designation, “pharmaceutical greed villain.” Daraprim became “the poster child for the issue of high drug prices.”
FDA Expands Ecstasy Access to Veterans with PTSD
In 2006, Johnathan Lubecky was deployed to Iraq. While fighting for his country, Johnathan faced constant enemy strikes, one of which resulted in a traumatic brain injury. Exposures to the horrors of war resulted in Johnathan developing post-traumatic stress disorder (PTSD).
As Insulin Prices Rise, Diabetics Turn to Black Markets
To avoid financial hardship and medical complications, many diabetics have turned to black markets.
FDA To Stop Regulating the Amount of Cherries in Frozen Cherry Pie
The FDA recently committed to deregulating the frozen cherry pie market.
Political Rhetoric Against Right-to-Try Laws Continues, Undermining Support for Medical Treatments of Last Resort
Ms. Joy Silver’s criticisms of right-to-try laws are ill-conceived.
FDA Approves Ketamine-Based Drug to Treat Difficult Cases of Depression
Despite its reputation as a party drug, Ketamine is now hailed as a “game-changing” treatment for types of depression that do not respond to typical treatment methods.
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